Executive Summary

Endo Pharmaceuticals is a global company which is focused on matters of improving the lives of patients and creating more value to everyone in the health sector. It is located in Northeastern US and headquartered in Malvern, Pennsylvania, United States.

The company deals with biotechnology, healthcare and pharmaceuticals. The company also provides the much needed healthcare solution to both America and internationally all over the whole world. The company offers many types of products and most of them are branded prescription products.

The company has expanded its territories by acquiring many other companies in the same field of healthcare thus taken the lager market in the wider United States.

Cases involved;

Opioid (OPANA) Litigation

This is the case where Endo Pharmaceuticals and other manufacturers of Opioid Opana have been accused of downplaying the risks of opioids and marketing the drugs as non addictive which led to massive prescription by the physicians and other healthcare personnel.

This turned the other way where many patients who used this drug had severe effects of addictive in nature and overdose. 

These litigations are still going on and no settlement yet has been reached.

History of Endo Pharmaceuticals

The history of Endo pharmaceuticals dates back to 1997 when three executives of DuPont Merck decided to buy out some products and all the laboratories with $277 million from Kelso and company financing. This led to the birth of Endo pharmaceuticals.

Subsidiaries of Endo Pharmaceuticals

1. Par Pharmaceuticals

This is a company that was established in the year 1978. It located in the northeastern United States and its headquarters being at Malvern, Pennsylvania, United States.

It develops, manufactures and markets and number of great cost effective and innovative generic pharmaceutical products around the United States.

Par Pharmaceuticals was acquired by Endo pharmaceuticals in May 2015 at a cost of $8.1 billion, being the highest cost acquisition up to date. Since then, par pharmaceuticals has been a champion in developing and manufacturing great products in the pharmaceutical industry.

Due to its uncompromising high quality products, the company has gained a lot of trust and relied upon by many patients and physicians all over the United States. This makes Endo pharmaceutical become among the top 5 biggest generic pharmaceutical companies in the entire United States.

1. Auxilium Pharmaceuticals

Auxilium Pharmaceuticals in a pharmaceutical company situated in the United States that was established in 1999 by Geraldine Henwood, and its focus is to develop, manufacture and market pharmaceutical products that associate mostly with urology and sexual health.

It is located in the northeastern United States and its headquarters are at Centerbrook, Connecticut, United States.

Auxilium pharmaceuticals was acquired by Endo pharmaceuticals in September 2014 at a total cost of $2.6 billion. The company has developed tremendously to meet the growing medical needs of the US citizens.

1. American Medical Systems

This is a pharmaceutical company located in the United States and its headquarters are in Minnetonka, Minnesota, United States. It was established in 1972 and deals with the supplier of medical devices and procedures which are aimed at curbing incontinence, erectile dysfunction, pelvic floor prolapse, benign prostatic hyperplasia and many other disorders of the pelvic in both men and women.

These effects in both men and women obviously affect the social life and diminish their lives significantly and American medical systems is there to ensure that this doesn’t happen and instead make this life prolonged.

American medical systems company was acquired by Endo pharmaceuticals in June 2011 at an agreed cost of $2.9 billion on cash terms. It became part of the Endo pharmaceutical family.

1. Qualitest Pharmaceuticals

Qualitest pharmaceuticals is a company based in US and headquartered at Huntsville, Alabama, United States. It is ranked as the sixth largest generic companies in the US based on prescription filled.

The company was acquired by Endo pharmaceuticals in September 2010 at a cost of $1.2 billion. 

The company mostly deals with generic products and distributes quite a great number to the US citizens.

1. Dava Pharmaceuticals

This company was established in 2004 and engages in developing and highly marketing of a wide portfolio of pharmaceutical products. It is headquartered in Fort Lee, New Jersey, United States. The company is keenly building and widening its product portfolio through partnerships, mergers, acquisitions and alliances. 

The company was acquired by Endo pharmaceuticals in August 2014 at accost of $575 million. Since then it has remained to be under Endo pharmaceuticals family and widening its product portfolio. 

1. Penwest Pharmaceuticals

This is the company that was founded in 1991 and it is headquartered in Patterson, New York, United States. The company develops and offers drugs to patients all over the United States.

The company was acquired by Endo pharmaceuticals in August 2010 at a cost agreed in shares of 30,810,778 shares at $4.2 each. This was approximately 82% of the shares making Endo Pharmaceuticals acquire the company.

Popular Products of Endo Pharmaceuticals

1. Oxymorphone (Opana)

This is an opioid agonist greatly indicated for the management of the pain which is very severe enough to require daily, around the clock and long term opioid treatment for which other alternative medications have proved to be inadequate. Its major role is to suppress and manage pain. Because of the addiction and misuse and major great risks of having an overdose, it is recommended that you reserve OPANA for use in patients only whose alternative treatments have totally failed to be effective.

Its dosage and administration should be; to be prescribed by only health practitioners, who have the knowledge in the use of opioids in pain management, use the much available lowest dosage possible, dosing should be based highly on severity of the pain and administer at least one to or prior to eating or after.

1. Dilatrate – SR

This is a drug manufactured and marketed by Endo pharmaceuticals which is used to treat chest pain. It can also be used for other purposes but through the doctors’ prescription.

When taking this drug, you may have some side effects like headache which goes away with time after taking this drug, dizziness and fast or slow heartbeat. When this effect comes out, it is recommended you see the doctor immediately.

The drug should be stored in places with room temperature; very dry place and much protected from light and always keep out of the reach of children.

1. Robaxin – 750

This is another popular product from Endo Pharmaceuticals whose generic name is Methocarbamol. It is a muscular relaxer which is used together with muscular therapy to treat muscle conditions like pain or injuries.

This drug should not be taken if you are allergic to it and if you are using opioids or narcotic medication and during early pregnancies because it can cause effects.

Take this medicine as recommended, do not take in larger or smaller quantities and reduce the dose after taking it for the first 2 or 3 days.

Its common side effects include dizziness, slow heartbeat, fever, nausea and vomiting and sleep problems.

1. Semplex – D

This drug’s generic name is Acrivastine and pseudoephedrine. This is a combination medicine which is normally used to treat or diagnose running or stuffy nose, watery eyes, itching and sneezing.

This drug should not be used at all with patients who have uncontrolled blood pressure or diabetes without a proper prescription of the doctor. When taking this medicine, always follow the doctors’ prescription or the prescription on the labels. Also avoid alcohol because it brings other side effects with this drug.

The common side effects of this drug include; dry mouth, nausea and headache. Always store in a cool dry places and away from the reach of children.

1. Endodan

Its generic name is called Oxycodone and Aspirin. This medicine is used to easy pain. It taken with or without food and when it causes stomach upsets, frequently take it with food.

1. Nascobal

This is a drug which is used to treat vitamin B12 deficiency in patients with anemia and other conditions. Its generic name is Cyanocobalamin. 

Its side effects are easy bruising and unusual bleeding, headache and runny nose.

Product Recalls and Lawsuits

1. Robaxin Recall 2018

In September 2018, Endo pharmaceuticals made a voluntary recall of two lots of Robaxin 750mg tablets. This was due to incorrect dosing on the label. The daily dosing that was on 750mg 100 count bottle packs was incorrect prompting for the recall. The daily dosing was erroneously indicated as two to four tablets four times a day instead of two tablets three times daily. This was a mistake that was not to be avoided because it could have led to overdose and not taking the correct dosage as per daily and for the correct number of days.

The patients who followed this incorrect dosing experienced drowsiness or dizziness. Up to this day, Endo pharmaceuticals has not received any complaint from this error and recall hence there is no any lawsuit concerning this recall.

1. Edex Recall 2017

Endo pharmaceuticals in February 2017 made a voluntary recall of Edex (Alprostadil for injection). The drug is normally used to treat male erectile dysfunction. This was because the clamp defect that is used in the manufacturing process and it was potentially seen that this might compromise the container closure and thus doubting its integrity. This hence could have resulted to affecting the assurance of the sterility of the whole drug. This can lead to very serious and grave effects in the long run.

The company then made this voluntary recall of this drug in order to avoid future repercussions.

The recalled product was estimated to be in 2 count cartons and was distributed between December 13 2016 and February 13 2017.

The company has not received any claim or complains concerning this recall and there is no issue whatsoever regarding this recall. The product is still fully in the market.

Litigation Settlements

1. Testosterone Liability Suits Settlement

Endo Pharmaceuticals made an agreement in June 2018 to settle over 1300 lawsuits of its testosterone replacement drug with an amount of over $200 million. The company was accused of marketing this drug in a very irresponsible way ignoring and not putting in mind all the potential risks involved.

Sources:

https://www.crunchbase.com/organization/endo-pharmaceuticals#section-current-team

http://www.endo.com/endopharma/our-products

https://www.empr.com/home/news/drugs-in-the-pipeline/carbavance-gets-priority-review-for-complicated-uti/

http://www.endo.com/about-us/history

https://www.drugs.com/manufacturer/endo-pharmaceuticals-inc-51.html

Executive Summary

This is a private pharmaceutical company which is highly committed to serving healthcare community and improving patient’s lives. It is located in Stamford, Connecticut, United States. The company has grown tremendously having acquired many other companies in the same field of healthcare.

The company has had its fare share of law suits which others are still pending up to now. The current lawsuit includes;

-Oxycontin Lawsuits

Purdue Pharma the maker of Oxycontin faces numerous lawsuits of its opioid painkiller Oxycontin. Many of these lawsuits filed claims that the company failed to warn patients of the side effects of the opioid Oxycontin which it produces and distributes to doctors for sale.

Many patients who used these opioid pain killers had severe side effects which led to a number of them being addicted and some died. Although some settlements were made and paid, many lawsuits are still pending and many people have not yet been settled because it affected thousands of people.

The targeted defendants are the company itself and the owners of the company the Sackler family. If these cases are settled and people paid then it means Purdue Company will pay a lot of money which might lead to it being declared bankrupt. The cases are ongoing and others are still on the process of starting up. 

History of Purdue Pharma

Purdue Pharma was established in 1892 by two physicians John Purdue and George Frederick. In 1952, the company was sold to Mortner and Raymond Sackler. These two have owned the company and hence the company finally became the Sackler family company and is privately owned like that by this family. The company has continuously grown acquiring and expanding speedily to other parts of United States.

Subsidiaries of Purdue Pharma

1. Imbrium Therapeutics

This is a clinical stage biopharmaceutical company which is dedicated solely through advancing medical science by developing new therapies in treating pain, cancer and disorders of the central nervous system.

Imbrium therapeutics was founded in 2019 as a subsidiary of Purdue Pharma with its area focus being therapy. It does this in full compliance of the laws governing the therapeutic and pharmaceutical industry.

1. Delphian Technology

The company was founded in 1999 which is based or located in Stamford Connectcut, United States. The company majorly focuses on development, manufacture and distribution of analytical instruments which are widely used in the pharmaceutical industry. 

The company is a subsidiary of Purdue Pharma and has Purdue to improve largely on the side of technology through this subsidiary. 

1. Rhodes Technologies

This is the company which is a subsidiary of Purdue Pharma. It normally engages on production, marketing and sale of mainly pharmaceutical ingredients plus chemicals and other forms of finished dosage of pharmaceutical products. This company was established in 1999 which is found in Washington United States. It has also grown and also acquiring some other pharmaceutical companies thus expanding widely the family of Purdue Pharma.

Popular Products of Purdue Pharma

1. Oxycontin

This is a product manufactured by Purdue pharma. Its generic name is Oxycodone. This is an opioid pain medication which is also called narcotic. It is a very strong medicine only prescribed when a patient requires an opioid in managing very severe pain which requires round the clock treatment in a daily basis.

This medicine is not used with people with Asthma or any blockage in the stomach or having any breathing problems. Should not be used by pregnant mothers and not taken along with alcohol. 

Its side effects include weak pulse, noisy breathing, confusion and convulsions.

1. Betadine

This is another drug from Purdue pharma which is used to prevent or treat bacterial infections. Its generic name is providone-iodine. It is should be used as per the prescription of the doctor.

Its side effects are like allergic reactions like rushes, itching, swollen or blistered skin. It has also very bad irritation where it is being used.

It should always be stored in a place with room temperature and always do not freeze. It should also be protected from heat.

1. Hysingla ER

Its generic name is Hydrocodone. This is an opioid pain medication. It is used for severe pain suppression and treatment. This medicine should not be used in large quantities because it can stop or slow breathing. Also taking too much can lead to addiction as opioids are mostly known for major addictions.

It has some side effects which includes; burning or pain when urinating, slow pulse or heart rate, noisy breathing, severe drowsiness and tremors.

1. Betasept

This is a medine for the skin. Its generic name is Chlorhexidine topical. It is used mainly to clean the skin in the process of preventing any infection that may be caused by skin injury, surgery and injections. It causes very rare allergic reactions which are life threatening.

This medicine should be used as directed by the doctor or as per labels indicated and do not use for longer periods or shorter periods than recommended or prescribed. 

Its side effects includes severe itching, swelling, blistering and severe irritation of the treated skin.

1. Dexmethylphenidate

This is a mild stimulant mostly to the central nervous system. It normally affects the chemicals which contribute to the impulse control in the brain. It is specifically used to treat ADHD (Attention Deficit Hyperactivity Disorder). This drug should not be used if you have glaucoma, severe anxiety and agitation.

Always take this medicine as prescribed by the doctor otherwise it may cause blood circulation problems, causing numbness or discoloration of fingers or toes. Avoid taking in the evening because it may cause sleep problems and always be careful when doing something that requires you to be alert after taking this medicine because it causes blurred vision and may impair your thinking.

1. Colace

Its generic name is Docusate. This is a drug that is used to treat constipation. It used to soften stool and makes bowel movements easier and softer to pass. This prevents rectal damage or pain which is normally caused by hard stools or the strain that comes when passing the bowels. But this drug should not be used when one has blockage in the intestines and when having stomach aches, or sick with nausea or vomiting.

The dosage for this medicine should be followed according to the doctors’ prescription but adults and children should not use the same dosage as it will lead to overdose or under dose of one of them.

The side effects of this drug are; rectal bleeding or irritation, vomiting and stomach cramps, pounding heartbeats and continued constipation.

1. Intermezzo

Its generic name is called Zolpidem Sublingual. It is a sedative which affects chemicals in the brain that becomes unbalanced and causes sleep problems. It is used to treat insomnia.

Product Recalls and Lawsuits

1. Hydromorph Contin Recall April 2019

Purdue Pharma made this recall because of the safety reasons. This is because the recalled lots had hydromorphone levels which were outside those that were labeled in the drug itself.

This recall targeted the public at large and the wholesalers and distributors. After this recall was made, no claim has been made concerning any effect from the labeling issue and still the recall is in process.

Litigation Settlements

1. $270 Million Opioid Settlement

Purdue Pharma reached a final settlement of $270 million in which it was sued for its opioid contribution to the deaths of many people.

Opioids are painkillers which are very strong and very high side effects when used. They are normally prescribed when other pain killer drugs have been used and failed totally then these opioid can be used but with high integrity prescription.

The lawsuit which was filed by Oklahoma which in its suit claimed that the company and other pharmaceutical companies selling and producing opioids deliberately and falsely downplayed the risks involved with the opioids and persuaded doctors to prescribe their painkillers without actually revealing the side effects.

These opioids made many people become addicts from using these painkillers which are only used in severe painkillers where the other treatments have totally failed. Also other were overdosed and many died through the use of these opioids and this is why these companies were sued for claiming the lives of many through this illegal sale of very deadly painkillers which are very strong and not rarely prescribed without prior prescriptions.

Purdue payment was to go the construction and maintenance of an addiction centre in Oklahoma University. 

Sources:

https://www.purduepharma.com/healthcare-professionals/products/

https://www.drugs.com/manufacturer/purdue-pharma-lp-160.html

https://www.bbc.com/news/business-47710332

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69658r-eng.php

http://money.com/money/5640480/oxycontin-opioid-crisis-purdue-pharma-sackler-family-lawsuits/

Executive Summary

AbbVie Inc. (AbbVie) is a research-based biopharmaceutical company. AbbVie is engaged in the discovery, development, manufacture and sale of a range of pharmaceutical products. Its products are focused on treating conditions, such as chronic autoimmune diseases in rheumatology, gastroenterology and dermatology; oncology, including blood cancers; virology, including hepatitis C virus (HCV) and human immunodeficiency virus (HIV); neurological disorders, such as Parkinson’s disease and multiple sclerosis; metabolic diseases, including thyroid disease and complications associated with cystic fibrosis, and other serious health conditions. 

History of Merck

On October 19, 2011, biopharma giant Abbott Laboratories announced its plan to separate into two publicly traded companies. The “new” Abbott Laboratories would specialize in diversified products including medical devices, diagnostic equipment and nutrition products, while AbbVie would operate as a research-based pharmaceutical manufacturer. The separation was effective January 1, 2013, and AbbVie was officially listed on the New York Stock Exchange (ABBV) on January 2, 2013.

According to Miles White, CEO at the time, the purpose of the split was to allow markets to value the two businesses separately; White said that investors would “benefit from two fundamentally different investment opportunities with distinct strategic profiles and business priorities.” Some investors were concerned that the split was done to protect the value of the device business from the loss of value facing the drug division due to the imminent expiration of patents on Humira, which accounted for about half of the drug division’s revenue. 

As of December 2015, the company employed in excess of 28,000 globally, and provided products to individuals in more than 170 countries.

Subsidiaries of AbbVie

The following companies are listed by the United States Securities and Exchange Commission as subsidiaries of AbbVie, as of December 2017:

AbbVie Biopharmaceuticals LLC	Delaware
AbbVie Bioresearch Center Inc.	Delaware
AbbVie Biotech Ventures Inc.	Delaware
AbbVie Biotherapeutics Inc.	Delaware
AbbVie Endocrine Inc.	Delaware
AbbVie Endocrinology Inc.	Delaware
AbbVie Holdings Inc.	Delaware
AbbVie Pharmaceuticals LLC	Delaware
AbbVie Products LLC	Georgia
AbbVie Purchasing LLC	Delaware
AbbVie Resources Inc.	Delaware
AbbVie Resources International Inc.	Delaware
AbbVie Respiratory LLC	Delaware
AbbVie Stemcentrx LLC	Delaware
AbbVie US Holdings LLC	Delaware
AbbVie US LLC	Delaware
AbbVie Ventures LLC	Delaware
Aeropharm Technology, LLC	Delaware
BioDisplay Technologies, Inc.	Illinois
Fremont Holding L.L.C.	Delaware
IEP Pharmaceutical Devices, LLC	Delaware
Knoll Pharmaceutical Company	New Jersey
KOS Pharmaceuticals, Inc.	Delaware
Life Properties Inc.	Delaware
Organics L.L.C.	Delaware
Pharmacyclics LLC	Delaware
Rowell Laboratories, Inc.	Minnesota
Sapphire Merger Sub, Inc.	Delaware
Unimed Pharmaceuticals, LLC	Delaware
Foreign Subsidiaries	Incorporation
AbbVie S.A.	Argentina
AbbVie Pty Ltd	Australia
AbbVie GmbH	Austria
AbbVie Bahamas Ltd.	Bahamas
AbbVie SA	Belgium
AbbVie Ltd	Bermuda
AbbVie Biotechnology Ltd	Bermuda
AbbVie Holdings Unlimited	Bermuda
AbbVie d.o.o.	Bosnia
AbbVie Farmacêutica Ltda.	Brazil
AbbVie Participações Ltda.	Brazil
AbbVie EOOD	Bulgaria
AbbVie Corporation	Canada
AbbVie Holdings Corporation	Canada
Pharmacyclics Cayman Ltd.	Cayman Islands
Stemcentrx Cayman Ltd.	Cayman Islands
AbbVie Productos Farmacéuticos Limitada	Chile
AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd.	China
Pharmacyclics (Shanghai) Management Consulting Services Limited	China
AbbVie S.A.S.	Colombia
AbbVie d.o.o.	Croatia
AbbVie Limited	Cyprus
AbbVie s.r.o.	Czech Republic
AbbVie A/S	Denmark
AbbVie, S.R.L.	Dominican Republic
AbbVie L.L.C.	Egypt
AbbVie Oy	Finland
AbbVie SAS	France
AbbVie Holdings SAS	France
Abbott Products GmbH	Germany
AbbVie Biotechnology GmbH	Germany
AbbVie Deutschland GmbH & Co. KG	Germany
AbbVie Komplementär GmbH	Germany
AbbVie Real Estate Management GmbH	Germany
AbbVie (Gibraltar) Holdings Limited	Gibraltar
AbbVie (Gibraltar) Limited	Gibraltar
AbbVie Pharmaceuticals Societe Anonyme	Greece
AbbVie, S.A.	Guatemala
AbbVie Limited	Hong Kong
AbbVie Kft.	Hungary
AbbVie Biopharmaceuticals Private Limited	India
AbbVie Ireland Holdings Limited	Ireland
AbbVie Ireland Unlimited Company	Ireland
AbbVie Limited	Ireland
AbbVie Manufacturing Management Limited	Ireland
Fournier Laboratories Ireland Ltd.	Ireland
Pharmacyclics (Europe) Limited	Ireland
AbbVie Biopharmaceuticals Ltd.	Israel
AbbVie S.r.l.	Italy
AbbVie GK	Japan
AbbVie Holdings KK	Japan
AbbVie UK Biopharmaceuticals Ltd	Jersey
AbbVie UK Ltd	Jersey
AbbVie Ltd	Korea, South
AbbVie SIA	Latvia
AbbVie UAB	Lithuania
AbbVie (Gibraltar) Holdings Limited Luxembourg S.C.S.	Luxembourg
AbbVie International S.à r.l.	Luxembourg
AbbVie Investments S.à r.l.	Luxembourg
AbbVie Overseas S.à r.l.	Luxembourg
AbbVie S.à r.l.	Luxembourg
AbbVie Sdn. Bhd.	Malaysia
AbbVie Farmacéuticos, S.A. de C.V.	Mexico
AbbVie B.V.	Netherlands
AbbVie Central Finance B.V.	Netherlands
AbbVie Finance B.V.	Netherlands
AbbVie Ireland NL B.V.	Netherlands
AbbVie Japan Holdings B.V.	Netherlands
AbbVie Logistics B.V	Netherlands
AbbVie Nederland Holdings B.V.	Netherlands
AbbVie Pharmaceuticals B.V.	Netherlands
AbbVie Research B.V.	Netherlands
AbbVie Venezuela B.V.	Netherlands
AbbVie Venezuela Holdings B.V.	Netherlands
AbbVie Limited	New Zealand
AbbVie AS	Norway
AbbVie, S. de R.L.	Panama
AbbVie Polska Sp. z o.o.	Poland
AbbVie Sp. z o.o.	Poland
AbbVie, L.da	Portugal
AbbVie Promoção, L.da	Portugal
AbbVie Corp	Puerto Rico
Knoll LLC	Puerto Rico
S.C. AbbVie S.R.L.	Romania
AbbVie Limited Liability Company	Russia
AbbVie Operations Singapore Pte. Ltd.	Singapore
AbbVie Pte. Ltd.	Singapore
AbbVie Holdings s.r.o.	Slovakia
AbbVie s.r.o.	Slovakia
AbbVie Biofarmacevtska družba d.o.o.	Slovenia
AbbVie (Pty) Ltd.	South Africa
AbbVie Spain, S.L.	Spain
Fundación AbbVie	Spain
AbbVie AB	Sweden
AbbVie AG	Switzerland
AbbVie Biopharmaceuticals GmbH	Switzerland
Pharmacyclics Switzerland GmbH	Switzerland
AbbVie Ltd.	Thailand
AbbVie Sarl	Tunisia
AbbVie Tıbbi İlaçlar Sanayi ve Ticaret Limited Şirketi	Turkey
AbbVie Australasia Holdings Limited	United Kingdom
AbbVie Biotherapeutics Limited	United Kingdom
AbbVie Investments Limited	United Kingdom
AbbVie Ltd	United Kingdom
AbbVie Trustee Company Limited	United Kingdom
AbbVie UK Holdco Limited	United Kingdom
AbbVie S.A.	Uruguay
AbbVie Pharmaceuticals SCA	Venezuela

Popular Products of AbbVie

AbbVie’s most popular products are the following:

1. Humira (adalimumab) – Humira is one of the most popular drugs in the world, selling USD 18 billion worth of the drug in 2017 alone. It is used in the treatment of rheumatoid arthritis and Crohn’s disease. It is very expensive, costing aroun USD 5,000 per prescription. It was responsible for 61% of AbbVie’s revenue in 2018. 
2. Imbruvica (ibrutinib) – Imbruvica is used to treat chronic lymphocytic leukemia (CLL), Waldenstrom’s macroglobulinemia, and as a second-line treatment for mantle cell lymphoma, marginal zone lymphoma, and chronic graft vs host disease. The typical cost of ibrutinib in the United States is about USD 148,000 a year.
3. Creon (Pancreatic enzymes) – Creon, or Pancreatic enzymes, and also known as pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease. They are used to treat malabsorption syndrome due to certain pancreatic problems. These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, or pancreatic cancer, among others. The preparation is taken by mouth.
4. Venclexta (venetoclax) is a BCL-2 inhibitor used to treat adults with CLL or SLL, with or without 17p deletion, who have received at least one prior treatment. In addition, Venclexta is used in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy.
5. Mavyret (glecaprevir/pibrentasvir) is approved in the United States and European Union (MAVIRET) for the treatment of patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). It is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.
6. Lupron (Leuprorelin) is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, and early puberty. It is given by injection into a muscle or under the skin.
7. AndroGel (Testosterone in gel) – AndroGel is a testosterone replacement therapy for males diagnosed with symptomatic low testosterone due to certain underlying conditions.
8. Marinol (Dronabinol) – AbbVie’s Marinol was the first FDA-approved cannabis drug. Solvay Pharmaceuticals developed the drug. It is an appetite stimulant, antiemetic, and sleep apnea reliever

Product Recalls and Lawsuits

1. Humira lawsuits blame the drug for fungal infections, nerve damage, and an increased risk of cancer in children and adolescents. In 2013, a jury ordered AbbVie to pay $2.24 million to a patient who suffered from a fungal infection. Some patients have died from these infections, according to the FDA.
2. More than 7,750 men have filed testosterone lawsuits against AbbVie and other manufacturers of testosterone replacement therapy products. Nearly 6,000 remained pending in federal court in Illinois in June 2018. AndroGel lawsuits blame the product for blood clots, heart attack, stroke and sudden death.
3. AbbVie’s multiple sclerosis drug Zinbryta was pulled from the shelves altogether in March 2018. It led to the deaths of three patients. The drug was a joint venture with Biogen. There were Reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, and patient deaths; possible severe immune reactions affecting other body organs
4. AbbVie’s Zemplar injection was recalled in 2015 because a single vial contained free floating glass particles. 
5. In 2013, AbbVie’s Synthroid had to be recalled because of a labelling error. 

Litigation Settlements

1. Depakote lawsuits say children suffered birth defects after their mothers took Depakote during pregnancy. AbbVie assumed all rights and responsibilities for Depakote when it separated from Abbott. In June 2018, a judge halted more than 600 lawsuits so lawyers on both sides could discuss settlements.
2. After a court ruling against AbbVie in April 2018, the company plans to settle other AndroGel cases, as of 2019. 

Sources:

https://investors.abbvie.com/stock-information/stock-quote

https://www.sec.gov/Archives/edgar/data/1551152/000155115218000014/abbv-20171231xex21.htm

https://www.statista.com/statistics/417063/revenue-of-abbvie-from-key-products/

https://www.investopedia.com/articles/markets/040115/how-abbvie-makes-its-money-abbv.asp

https://investors.abbvie.com/static-files/47b78f29-de86-46fd-ae82-83878c1a72f1

https://www.drugwatch.com/manufacturers/abbvie/

https://www.pharmaceutical-technology.com/?s=abbvie

Executive Summary

Takeda Pharmaceuticals is a global biopharmaceutical company which is patient focused and value based which is highly committed in changing people’s lives to the better and giving them a brighter future though healthcare. The company has its presence over 80 countries all over the world having leading positions in Japan and United States.

The US position leads in all Takeda Revenue giving 48%, Japan giving 19% and the rest of the world giving out 33%. 

-Takeda Lawsuits

Takeda Pharmaceuticals is facing so many lawsuits concerning it diabetes type 2 drug Actos. The patients who were prescribed this drug started feeling and experiencing very adverse reactions from the side effects of this medicine. 

This reactions and problems which were caused by Actos side effects were; bladder cancer and heart failure. These two became the main reasons for the many lawsuits filed against Takeda pharmaceuticals. 

The company has been accused of hiding information about the side effects of Actos hence causing all this problems to patients who used this drug.

Many of these charges have been filed as MDL (Multi District Litigations) where several federal lawsuits have been grouped together into one court case so that the process of litigation can be easier and simpler.

History of Takeda Pharmaceuticals

Takeda Pharmaceuticals was founded in 1998 and was ranked as one of the top most Pharmaceutical companies in the United States. Their success has been entirely brought by their drug for treating type 2 diabetes.

The company was originally founded in Osaka Japan in 1781 where it began importing the pharmaceutical products from the west in the same year and at that time it was known as cooperative union not Takeda. In 1925, they changed their name and was called Chobel Takeda & company ltd and had grown that time its net worth being approximately $1 million.

In the of the Second World War, Takeda supplied Penicillin and B vitamins and after the end of the war, it started supplying its stock internationally. The company grew since then expanding its US and European markets.

Subsidiaries of Takeda Pharmaceuticals

1. Shire PLC

Takeda pharmaceuticals in January 2019 acquired Shire plc the Irish based drug maker at a cost of $57 billion. This deal almost doubled Takeda revenue in the larger US region. 

Shire plc deals with the development of medicines like for hemophilia and others that will expand Takeda pharmaceuticals product base and help the company achieve its goals.

1. TiGenix

In August 2018, Takeda Pharmaceuticals acquired TiGenix at a cost of $608 million through the purchase of ordinary shares. Though this purchase, TiGenix became a whole subsidiary of Takeda pharmaceuticals.

TiGenix is a biopharmaceutical company which develops stem cell therapies. It is locally mandated to treat very complex perianal fistulas in these patients with non active luminal diseases who have inadequate response to conventional therapy.

1. Millennium Pharmaceuticals

In April 2008, Takeda Pharmaceuticals acquired biotechnology company Millennium Pharmaceuticals at a cost of $8.8 billion. This is a US based pharmaceuticals which deals mostly with developing and manufacturing cancer drugs.

This acquisition saw Takeda pharmaceuticals own fully the US based company and secured its promising pipelines and technologies developed by the company at large.

It also cemented the deal that Millennium’s main cancer drug Velcade to be added to Takeda’s products portfolio.

1. Nihon Pharmaceuticals

This is another subsidiary of Takeda Pharmaceuticals which was established in 1960. It deals with development and manufacture of pharmaceutical products in the Japan and it based in Tokyo Japan. 

This added to the Takeda family and its widening product portfolios all over the world.

1. Nycomed Pharmaceuticals

This is a pharmaceutical company situated in Johannesburg South Africa which was established in 1996 in which it markets and sells Takeda’s pharmaceutical products in the larger South Africa. This company was acquired in 2011 by Takeda Pharmaceuticals at a cost of $12.9billion on cash basis. The company’s focus was to improve on emerging markets in Asia, Europe and The US markets.

Popular Products of Takeda Pharmaceuticals

There are many products that are developed, manufactured and distributed by Takeda Pharmaceuticals Company both the main and its subsidiaries. They include the following;

1. Prevacid

Its generic name is Lansoprazole and formulated as 15mg, 30mg and granules in caps. It is a proton pump inhibitor which decreases the high amount of acid which is being produced in the stomach.

It is normally used to treat and in the prevention of intestinal and stomach ulcers and the also prevents the danger and damage caused to the esophagus from excessive stomach acids.

Over the counter prevacid is also used to treat heartburn that occurs frequently usually once or twice a week but not very severe.

Use Prevacid carefully as directed or prescribed by the doctor or as directed on the label. The capsule should be swallowed whole and not crushed. Be careful too not to overdose or under dose because it can then lead to other side effects which are life threatening.

1. Dexilant

This is another popular product which is manufactured and distributed by Takeda Pharmaceuticals. Its generic name is Dexlansoprazole. It decreases the amount of acid which is produced in the stomach.

Dexilant is also used to treat heartburn which is normally caused by gastroesophageal reflux disease (GERD) and to heal any damage caused to the esophagus from the acids which are produced in the stomach.

Dexilant can cause kidney problems, new or worsening symptoms of Lupus and broken bones if taking Dexilant daily or more than once per day and even long term.

Taking Dexilant should be strictly followed according to the prescription label or the doctor’s prescription and advice. Do not overdose or under dose because it can also bring other side effects.

1. Actos

Its generic name is called Pioglitazone. This is an oral medicine for diabetes which is used to control blood sugars. It is used together with diet and exercise to improve the blood sugar controls in adults with diabetes type 2. It is not for treating type 1 diabetes.

This medicine is taken once daily with or without food. Low blood sugar (Hypoglycemia) can happen to anyone with diabetes. The doctor can sometimes prescribe glucagon emergency injection kit to be used in case one has very severe hypoglycemia and in the process cannot eat or drink anything.

In taking this drug, follow the doctor’s prescription carefully and do not over or under dose. Always store this medicine at a room temperature where there is no heat, moisture and light. Keep the bottle tightly closed when not in use.

1. Duetact

Its generic name is called glimepiride and pioglitazone. 

Duetact is a combination of oral diabetes medicines which are glimepiride and pioglitazone which helps in controlling blood sugar levels. It is used together with diet and exercise to improve the control of blood sugar in grownups with type 2 diabetes mellitus. Duetact is not at all used to treat diabetes type 1.

Duetact can sometimes cause heart congestion or failure. It should not be used with patients who have cancer unless directed by the doctor. Also it is not for children but only for adults. Always should be taken as per the doctor’s prescription to avoid over or under dosing.

1. Colcrys

This is a Takeda pharmaceutical product whose generic name is Colchicine. This drug is designed to respond to acidic uric crystals thus reducing swelling and pain. This drug has been approved to treat familial Mediterranean fever in adults and children aged 4 years and above and in treating gout only in adults. The medicine is also used to prevent gout and the symptoms of behcets syndrome but it is not a cure for gout.

The common side effects of Colcrys include, muscle pain or weakness, diarrhea, vomiting and stomach pains

1. Leuprorelin Acetate

This is a GnRHa (Gonadotropin releasing hormone agonist) used for the treatment of hormone responsive diseases like cancer e.g. prostate cancer and breast cancer in women

It is also a medicine which is used in treating children with central precocious puberty, infertility and women with endometriosis. It also improves anemia in women with fibroids.

1. Vortioxetine

Its brand name is Trintellix which one of the popular products developed, manufactured and distributed by Takeda Pharmaceuticals. It is mainly used to treat major depressive disorder (MDD).

Product Recalls and Lawsuits

1. Omontys (Peginesatide) Injection Recall

On February 2013, Takeda pharmaceuticals together with Affymax Inc Company made a voluntary recall of all lots of Omontys injection up to the consumer level.

This recall was made because of emerging post marketing reports of very serious hypersensitivity reactions which can be life threatening including anaphylaxis.

This medicine is mainly used in the treatment of anemia. There has been few cases and the company is investigating these issues. No lawsuits have been filed yet concerning this recall.

1. Pamol Recall 2017

In February 2017, Takeda pharmaceuticals made a voluntary recall of pamol, only some patch which was packed in packs of 300 film coated tablets. This was because there was a discovery of Ibumetin 600mg which contains ibubrofen in some packs.

These two medicines are used to treat mild pains but they work in totally different ways and it was anticipated that they may cause adverse or severe reactions

Litigation Settlements

1. $2.4 Billion Settlement of Actos Litigations

In April 2015, Takeda pharmaceuticals settled to pay over 9000 lawsuits mostly of bladder cancer litigations that emerged from the use of Actos. Many patients incurred injuries from the use of this drug resulting to too many lawsuits of which others are still pending which are not yet finalized or settled.

Sources:

https://www.empr.com/manufacture/takeda-pharmaceutical-company/

https://www.drugs.com/manufacturer/takeda-pharmaceuticals-u-s-a-inc-137.html

https://www.drugdangers.com/manufacturers/takeda-pharmaceuticals/

https://www.takeda.com/who-we-are/company-information/company-facts/

https://www.reuters.com/article/us-millennium/takeda-to-buy-millennium-pharma-for-8-8-billion-idUST18218420080410

https://laegemiddelstyrelsen.dk/en/news/2017/takeda-pharma-as-recalls-batch-of-pamol-in-packs-of-300-film-coated-tablets/

Executive Summary

Actavis Generics (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan Inc) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States.

As of 2019, Actavis, Inc. no longer exists in the United States. The brand name component of the company is now renamed Allergan, and the generic component of the company has been sold to Teva Pharmaceuticals.

History of Actavis

In 1993, Actavis, then Watson, announced its initial public offering (IPO) of shares of common stock. The company was initially listed on the NASDAQ under the ticker symbol WATS. The company moved to the New York Stock Exchange (NYSE) in 1997, and began trading under the symbol WPI.

In 2011, the company moved its corporate headquarters from Corona, California to Parsippany, New Jersey. The new LEED-certified corporate headquarters at the Morris Corporate Center in Parsippany was formally dedicated on June 9, 2011.

In November 2012, Watson acquired the Switzerland-based, global generics company Actavis Group for €4.25 billion, creating the world’s third largest generics company, with a leading position in key established commercial markets including the US, the UK, Nordics, Canada, Australia, and emerging markets in Central and Eastern Europe, and Russia. Following the acquisition, Watson adopted Actavis’ name for its global operations.

In November 2014, Actavis PLC announced its intention to acquire Allergan Inc, the manufacturer of Botox. Completion of the deal would increase its market capitalization to $147 billion. On March 17, 2015, Actavis PLC completed the acquisition of Allergan Inc in a cash and equity transaction valued at approximately $70.5 billion. The combination created a $23 billion diversified global pharmaceutical company with commercial reach across 100 countries. In June 2015, Actavis PLC officially changed its name to Allergan PLC. On June 15, 2015, Actavis plc changed its name to Allergan plc, but the company’s U.S. and Canadian generics business will continue to operate under the Actavis name. 

In July 2015, Allergan PLC announced it would sell its Generics division of the company, including Anda Inc, to Teva Pharmaceuticals for $40.5 billion.

Subsidiaries of Actavis

While Actavis itself is a subsidiary of Teva Pharmaceuticals, it is also the parent of a number of companies, namely: 

1. Auden McKenzie Holdings
2. Durata Therapeutics
3. Forest Laboratories
4. Furiex Pharmaceuticals
5. Aptalis Pharma
6. Galen
7. Warner Chilcott PLC
8. Procter & Gamble’s prescription drug unit
9. Watson Pharma
10. Andrx Corporation
11. Arrow Group
12. Eden Biodesign
13. Specifar Pharmaceuticals SA
14. Ascent Pharmahealth Ltd
15. Actavis Group

Popular Products of AbbVie

AbbVie’s most popular products are the following:

1. Actonel (risedronic acid) is used to treat the complications of osteoporosis.
2. Androderm patch (testosterone) is a transdermal patch used to treat issues with low testosterone levels as a result of surgery, disease, or some other disorder.
3. Several different generic antidepressant medications, including selective serotonin reuptake inhibitors and tricyclic antidepressants, were manufactured by the company.
4. Several different generic benzodiazepine medications were manufactured by the company.
5. Botox (botulinum toxin) is an extremely neurotoxic amino acid produced by bacteria, such as Clostridium botulinum. This substance interferes with the release of the neurotransmitter acetylcholine, which can result in paralysis. As a medicine, it has a number of uses, including both cosmetic and medical uses.
6. Enablax (darifenacin) and Gelnique (oxybutynin) are used to treat urinary incontinence.
7. Latisse (bimatoprost) is used as eye drops to control glaucoma and in the management of the ocular hypertension that often occurs with glaucoma.
8. Linzess (linaclotide) is used for treatment of constipation-predominant irritable bowel syndrome and chronic idiopathic constipation.
9. Namenda and Namenda XR (memantine) is a drug that is used in the treatment of Alzheimer’s disease and related dementias, especially in the moderate to severe stages. The drug cannot cure Alzheimer’s disease or stop the progression of the disorder, but there is some research that suggests it may slow the progression of the disorder in some individuals.
10. Norco (acetaminophen and hydrocodone) was produced by Watson Pharmaceuticals, which was acquired by Actavis, Inc. They also produced generic forms of acetaminophen and hydrocodone. Hydrocodone is classified as a Schedule II controlled substance by the United States Drug Enforcement Administration (DEA).
11. Ozurdex (dexamethasone) is used to treat hypertension.
12. Generic forms of the opiate drug oxycodone were marketed by Actavis, Inc. These included oxycodone (OxyContin) and a generic form of acetaminophen and oxycodone (Percocet). Oxycodone is classified as a Schedule II controlled substance by the DEA.
13. Restasis (ciclosporin) is an immunosuppressive medication that has a number of uses, including treating Crohn’s disease, rheumatoid arthritis, and the rejection of new organs after organ transplant surgery.
14. Teflaro (ceftaroline fosamil) is an antibiotic that can be used to treat MRSA infections.
15. A generic form of oxymorphone is classified as a Schedule II controlled substance by the DEA and used to control pain.
16. Generic forms of hydrocodone/ibuprofen (Vicoprofen) are used to control pain.

Product Recalls and Lawsuits

1. One of the glaring legal issues that Actavis, Inc. faced was its decision to discontinue its drug Namenda in favor of marketing the extended-release version Namenda XR (the extended-release version of memantine, the active ingredient in Namenda). Many onlookers viewed this as an attempt by the company to force out companies that had created generic versions of Namenda because these companies would not be able to provide patients with a drug similar to Namenda XR and patients who had been taking Namenda XR would not adapt to generic immediate-release versions of the drug. A pending lawsuit by the Attorney General of the United States at the time, Eric T. Schneiderman, led to Actavis, Inc. eventually abandoning their plans and the potential markup of memantine, which would have been quite significant.
2. Actavis, Inc. was included in a large lawsuit by the City of Chicago and the State of Illinois regarding the serious issue of prescription drug abuse in the United States. The lawsuit accused several companies, including Actavis, Inc., of illegally marketing these drugs and increasing the number of people addicted to them.
3. Numerous lawsuits have been filed as a result of misuse of testosterone therapy for “Low-T” syndrome, which became a marketing strategy for several pharmaceutical companies that already had medications to treat low testosterone in individuals who had other medical conditions. The Low-T syndrome associated with normal aging is not an actual syndrome in most cases, but a natural aspect of getting older. Individuals using the product Androderm and suffering side effects, such as cardiovascular effects or increased risk of cancer, have been involved in numerous suits against Actavis, Inc. In 2017, Teva Pharmaceuticals requested that it be dropped from the Androderm lawsuit.
4. A number of pharmaceutical companies, including Teva Pharmaceuticals and Allergan, are being considered for a large lawsuit alleging the companies of engaging in illegal price-fixing strategies.

Litigation Settlements

1. In 2018, Actavis settled 500 Androderm cases. Though no potential settlement order has been released, the judge in that case cited putting a stay on all Androderm claims against Actavis would allow parties to dedicate time and energy to finalize the agreement. The first bellwether trial date (August 6, 2018) for Androderm lawsuits has not been vacated yet.
2. Actavis has been involved in a number of patent litigation settlements. Most notably, in the 2013 US Supreme Court case FTC vs. Actavis, the Court held that the FTC could make an antitrust challenge under the rule of reason against a so-called pay-for-delay agreement, also referred to as a reverse payment patent settlement. Such an agreement is one in which a drug patentee pays another company, ordinarily a generic drug manufacturer, to stay out of the market, thus avoiding generic competition and a challenge to patent validity. 
3. In 2014, Actavis announced that it has entered into an agreement with Pfizer, Inc. to settle all outstanding patent litigation related to Actavis’ generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.  Celebrex is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.

Sources:

https://en.wikipedia.org/wiki/Actavis#In_popular_culture

http://phx.corporate-ir.net/phoenix.zhtml?c=65778&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwODU4MDYyJkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3

https://www.sec.gov/Archives/edgar/data/1578845/000119312515052898/d842874d10k.htm

https://www.drugwatch.com/manufacturers/allergan/

https://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industries

http://www.vault.com/company-profiles/pharmaceuticals-and-biotechnology/watson-pharmaceuticals,-inc/company-overview.aspx

https://www.allergan.com/investors/m-a-activities/allergan-acquisition

Executive Summary

Eisai Co., Ltd. is a pharmaceutical company founded on December 6, 1941, and is headquartered in 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. The company’s United States headquarters are in 100 Tice Boulevard Woodcliff Lake, NJ.

Eisai is engaged in the research and development, manufacture, sale and import and export of pharmaceuticals. The Company’s business segments include pharmaceutical segment and other segment. The pharmaceutical segment is engaged in the research, develop, manufacture and sale of pharmaceuticals for medical use, generic drugs, general medicines, among others. The other segment consists of pharmaceutical raw materials, logistics services and business services businesses.

History of Eisai

Nihon Eisai Co. Ltd. was established in 1941. In 1944, a merger with Sakuragaoka Research Laboratory resulted in creation of Eisai Co. Ltd. The American subsidiary of the company, Eisai Inc., was established in 1995.

In 1996, Eisai received approval from the United States Food and Drug Administration (USFDA) for Aricept (donepezil), a drug discovered in the company’s labs and co-marketed with Pfizer. Three years later in 1999, the company received USFDA approval for Aciphex (rabeprazole), a drug co-marketed with Johnson & Johnson.

In September 2006, the company acquired four oncology products from Ligand Pharmaceuticals.

In April 2007, Eisai acquired Exton, Pennsylvania-based Morphotek, a company developing therapeutic monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, and infectious diseases.

In December 2007, Eisai acquired MGI Pharma, a company specializing in oncology, for $3.9 billion USD. This event brought Dacogen (decitabine), Aloxi (palonosetron), Hexalen (altretamine) for ovarian cancer, and the Gliadel Wafer (carmustine) for brain tumors into the Eisai product portfolio.

Very recently, in 2018, Eisai agreed upon a strategic collaboration for the drug Lenvima with Merck & Co. The company also opened a new Suzhou plant in China. Lenvima is also launched in China.

In 2019, Eisai, Co., Ltd. established the Epochal Precision Anti-Cancer Therapeutics (EPAT) in Exton, PA. EPAT focuses on oncology drug development utilizing Eisai’s unique Antibody-Drug Conjugate (ADC) technology and proprietary payloads. Utilizing the insights gained from the AiM Institute, the Center will harness the power of human genetics to develop next-generation medicines for Alzheimer’s disease (AD) and other dementias.

Subsidiaries of Eisai

Eisai Co., Ltd. has a number of subsidiaries, including but not limited to: 

1. Elmed Eisai Co., Ltd. 
2. KAN Research Institute, Inc. 
3. Eisai Distribution Co. Ltd. 
4. Sunplanet Co., Ltd. 
5. Morphotek, Inc. 
6. H3 Biomedicine Inc. 
7. Bracco-Eisai Co., Ltd. 

Popular Products of Eisai

Eisai positions “neurology” and “oncology” as two strategically important areas.

Eisai’s most popular products are the following:

1. Actonel (risedronic acid) – Osteoporosis (Japan)
2. Aloxi (palonosetron) – Chemotherapy-induced nausea and vomiting
3. Aricept (donepezil) – Mild to moderate dementia for Alzheimer’s Disease patients. This product accounted for 40% of the company’s revenue, as of March 2010.  
4. Banzel/Inovelon (rufinamide) – Seizures related to Lennox-Gastaut Syndrome
5. Fragmin (dalteparin) – Deep vein thrombosis and pulmonary embolism
6. Fycompa (perampanel) – Partial-onset seizures
7. Halaven (eribulin) – Metastatic breast cancer
8. Iomeron (iomeprol) – Non-ionic contrast medium
9. Methylcobal (methylcobalamin) – Peripheral neuropathy
10. Myonal (eperisone) – Muscle relaxant
11. Selbex (teprenone) – Gastric ulcers and gastritis
12. Zonegran (zonisamide) – Partial-onset seizures
13. Gliadel Wafer (carmustine) – Treatment for Brain Tumors

Eisai’s top drugs in the United States are:

1. Lenvima (lenvatinib) – Thyroid Cancer or Kidney Cancer
2. Banzel/Inovelon (rufinamide) – Seizures related to Lennox-Gastaut Syndrome
3. Halaven (eribulin) – Metastatic breast cancer
4. Fycompa (perampanel) – Partial-onset seizures
5. Aciphex/Pariet (rabeprazole) – Gastroesophageal reflux disease
6. Belviq (lorcaserin) – Obesity

Product Recalls and Lawsuits

1. In 2011, Eisai recalled their Chocola BB Sparkling (Vitamin Drink) due to mislabeling of nutritional information. Specifically, Carbohydrates 14g has been mislabeled as Carbohydrates 14mg. As the product label does not comply with labeling standards required under the Health Promotion Act and other related laws of Japan, Eisai decided to recall the product in order to correct the error.
2. In 2016, Eisai voluntary recalled and discontinued the sales of egg white lysozyme preparation Neuzym. This came after a committee found that the medical usefulness of the product had decreased. 

Litigation Settlements

1. In 2015, Eisai entered into a settlement with Glenmark Pharmaceuticals to resolve a patent dispute related to Eisai’s Banzel (rufinamide) in the United States. 
2. In 2010, Eisai paid USD11 million to Elan to resolve civil liability for off-label marketing of Elan’s drug Zonegran. 

Sources:

https://www.eisai.com/ir/library/report/pdf/e105_02.pdf

https://www.eisai.com/company/profile/index.html

https://en.wikipedia.org/wiki/Eisai_(company)

https://www.prnewswire.com/news-releases/eisai-and-glenmark-reach-settlement-over-generic-version-of-banzel-rufinamide-300075151.html

https://www.marketwatch.com/investing/stock/esaly

Executive Summary

Novartis is a biotechnology healthcare company which is providing many solutions to the ever increasing needs of patients all over the globe. The company is situated in Basel Switzerland. The main focus of the company is to discover many new ways of improving and further extending peoples’ lives.

The company applies its expertise mainly in innovations and science to the challenges facing the health sector in the world today and this makes responsibility to be its core part in their business strategy.

The company although has had a good run and growth, it has had also its share of cases and liabilities. The cases that Novartis is involved in include:

-Doctor Kickbacks Allegations Lawsuit

This is a US government lawsuit accusing Novartis of paying kickbacks in millions of dollars to doctors so that they can prescribe their drugs.

This may cause Novartis to pay a lot of money as fines and other damages if found guilty. The case is ongoing and has not reached to settlement.

History of Novartis Pharmaceuticals

Novartis Company was a result of a merger of two companies, Ciba-Geigy and Sandoz which had very rich history of innovative. This merger then became Novartis and started producing chemicals and then eventually pharmaceuticals. These companies before the merger developed a great passion for developing and marketing new products, a trait that was fully exercised by Novartis pharmaceuticals.

This company throughout has developed this passion and has ensured the development, manufacture and distribution of new products that give human beings value and contributes to their progress through the advances made in science and health.

Subsidiaries of Novartis Pharmaceuticals

1. Alcon

In April 2008, Novartis Pharmaceuticals acquired Alcon, a company based in USA at a cost of $39 billion. Alcon Company mainly deals with eye problems. This acquisition ensured Novartis eye care problems were catered for and boosted its business so much.

Alcon Company is situated in Texas United States. It is a global leader in the care of the eye which is brilliantly dedicated to make sure people see carefully and clearly. It is the largest in the world in the side of device eye care with more emphasis on vision care and surgical. The company always puts patient care first and it was a big acquisition of Novartis businesswise.

1. Avexis

Novartis pharmaceuticals acquired Avexis, a gene therapy company at a cost of $8.7 billion in April 2018. Avexis is located in Bannockburn, Illinois, United States and deals with the therapy of the spinal muscular. 

Avexis deals with very rare diseases which create problems in man and also very life threatening. This are diseases which make human beings devastated so much and often requires some more attention which Avexis is doing.

The company’s initial product is AVXS-101 which a gene therapy product that has already gone through the first stage and on the trial and will be used specifically for treating Muscular Atrophy Type 1. 

1. Endocyte

In October 2018, Novartis pharmaceuticals acquired Endocyte which a US cancer treatment drugmaker at a cost of $2.1 billion in cash. This was a move for Novartis to expand more in the radiopharmaceuticals business

Endocyte is a biopharmaceutical company established in 1996 in the US which majorly develops receptor targeted therapeutics which is used to treat inflammatory diseases and cancer. It is located in Indiana United States.

The company provides solutions to the patients mostly in the treatment of renal and ovarian cancer and also various tumors which further include cancers of the blood, lungs and breast.

1. Ebewe Pharma

 In May 2009, Novartis Pharmaceuticals acquired Ebewe pharma at a cost of $1.2 billion in cash. The company was established in 1934 in Vienna Austria and its headquarters are at Unterach lake Attersee.

Ebewe pharma is a company that has specialized in very professional processing of effective substances into the sterile medicine injections. It focuses on the fields of specialized pharmaceuticals like oncology. This makes this company very popular and very efficient in this field. 

The company produces parenteral medicines, vials, ampoules and pre filled syringe. The company also engages in ensuring protection of people globally and according to the internationally accepted standards.

1. Hexal AG

Hexal AG is a company located in Germany and its headquarters are in Holzkirchen. In February 2005, Novartis acquired Hexal AG at a cost of $8.3 billion cash which is a generic company making Novartis to become the largest generic company in the world replacing Teva pharmaceuticals.

The company was established in 1986 and was called Hexal chemie and later changed its name in 1995 to Hexal AG.

Hexal AG mainly develops, manufactures and markets mostly generic drugs. This company offers prescription for over the counter medicines for diseases like Asthma, cancer, high blood pressure, common cold, pain therapy medicines.

1. EsbaTech AG

This company is located in Switzerland and was established in 1998. The company is based in Schlieren Switzerland.

In September 2009, Novartis acquired EsbaTech AG at accost of $589 million. It mainly focuses on the fully human antibody fragments majorly for therapeutic applications which it applies the single framework of the single chain antibody.

The company delivers very high concentrations of the antibody fragments to the targeted sites. The antibody fragment is derived from the human antibody fragment called scaffolds.

Popular Products of Novartis Pharmaceuticals

1. Diovan (Valsartan)

This is a Novartis pharmaceutical company product which is used to treat hypertension and to lower the blood pressure which reduces the many risks of fatal and non fatal cardiovascular situations and strokes which are in the primary level.

It also reduces the risk of getting heart failure which it has done insignificantly to minimize hospitalizations of heart failure patients.

Its dosage is available to adults and children from the age of 6 to 16 years. For the use of Diovan tablets, it is recommended that it should be used for adults and children who can swallow it full and for other children who cannot swallow the tablet, the suspension can do better.

1. Ofatumumab Arzerra

This is a product which is produced by Novartis pharmaceuticals which is used in the treatment of lymphocytic leukemia. It is a human antibody which induces the killing of tumor lines and primary tumor cells.

This drug was originally developed by Genmab but it is currently being developed by Novartis.

1. Ciprodex

Ciprodex is a product of Novartis pharmaceuticals which is used in the treatment of bacterial ear infections. It also used to treat in children middle ear infections with ear tubes and also the outer ear infections in both children and adults.

This medicine works by actually stopping the bacteria which mainly reduces the ear swelling and the ear discomfort.

1. Secukinumab Cosentyx

This is a prescription medicine which is used to treat adults who have moderate to severe plaque psoriasis which involves very large areas of the body. It is also used to treat patients with active arthritis and active ankylosing spondylitis.

This medicine when used may easily lower your immune system which fights infections hence increasing rapidly the risk of having many infections in the body. It should be used as prescribed by the doctor to avoid over or under dosing.

1. Emedine

Emedine is another product which is produced by Novartis pharmaceuticals. It is mainly used to relieve itching, redness, and swelling of the eyes from allergies. This works by blocking certain natural substances in the body or eyes that brings about or causes these allergies.

This medicine is prescribed in drops and should be applied through this eye drops. Always observe cleanliness to avoid contamination to the eye because of its sensitivity nature.

1. Femara (Letrozole)

This is also another product from Novartis pharmaceuticals which is mainly used to treat certain types of breast cancer in women who have attained the level of menopause. After treatment, the cancer may return back and it is also used to prevent this return back. Estrogen is a natural hormone in the human body which makes the breast cancer to grow very fast. Letrozole does this work of highly reducing the growth of this hormone estrogen in the body thus reducing also the growth of this breast cancer in the body.

It should be used purely according to the doctors’ prescription.

Product Recalls and Lawsuits

1. Valsartan Recall

In July 2013, the FDA and Novartis made a recall on valsartan products outside USA. This was because the products used to manufacture them did not come from the same place and hence it might different ingredients. This only affected the countries outside the US where this drug is sold.

1. Recall of Zofran and Entresto packages

Novartis made this recall in July 2018. This recall was not due to safety or any medical reason but due to the packaging reason of the tablets. The packaging was not child resistant hence posing danger to the children because it is easier for the children to swallow these products.

The products in bottles are not affected at all.

Litigation Settlements

1. Elidel Cream $35 million settlement

In October 2016, Novartis Company agreed to pay $35 million which was to settle a lawsuit which challenged the company for promoting illegally a prescription of a skin cream for toddlers and infants.

The company was accused of widening the market of Elidel cream and that it should be applied 80% to the body and it never put openly that it can cause cancer. Many people were overstretched and they paid more which also resulted in Medicaid. This led to many suits from the effected sales representatives and the patients as well. 

Novartis agreed to pay and this issue was settled.

Sources:

https://www.crunchbase.com/organization/novartis#section-overview

https://www.pharma.us.novartis.com/product-list

https://www.cnbc.com/2018/04/09/novartis-enters-deal-to-acquire-avexis-for-8-point-7-billion.html

https://www.crunchbase.com/organization/endocyte#section-overview

https://www.ft.com/content/323cd2d0-83d5-11d9-ad81-00000e2511c8

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=983882

https://www.webmd.com/drugs/2/search?type=drugs&query=cosentyx

https://www.statnews.com/pharmalot/2016/10/05/novartis-35-million-improper-marketing/

Executive Summary

Zhejiang Huahai Pharmaceuticals Co., Ltd. is a China-based company, principally engaged in the manufacture and distribution of active pharmaceutical ingredients (APIs), intermediates and preparations. The Company’s main products are classified as -pril series, -sartan series and preparations, including irbesartan tablets, paroxetine hydrochloride tablets, risperidone tablets, fosinopril sodium tablets, as well as irbesartan and hydrochlorothinzide tablets, among others. The Company also provides related technical support services. The Company distributes its products in domestic and overseas markets.

It was founded in 1989, and is headquartered in Zhejiang Province of China. It has a total staff of over 6,500 people and has more than 40 branches and subsidiaries around the world, including the United States, Japan, Germany, Russia, Spain, and India. The company is one of the global leading manufacturers for cardiovascular and central nerve system, products. 

In the United States, Huahai US, Inc. develops, acquires, licenses, registers, markets, and distributes prescribed generic pharmaceutical products. It offers cardiovascular, CNS, Alzheimer’s, anti-diabetes, and anti-HIV products to the US market.  Huahai US, Inc. is a wholly owned subsidiary of Zhejiang Huahai Pharmaceutical Co. Ltd., the first Chinese manufacturer approved by the US FDA in 2007 for manufacturing finished products. It was founded in 2004 and is located in Cranbury, New Jersey.

History of Zhejiang Huahai Pharmaceuticals

Zhejiang Huahai was established in January 1989 as Linhai Xunquiao Synthetic Chemical Factory. It was renamed Zhejiang Huahai Pharma in April 1997, and set up their first wholly-owned subsidiary in August 1998. In January 2000, the company won the title of Top 500 Private Enterprises in China for the first time. 

In the United States, Huahai US was established in 2004, being the first Chinese pharmaceutical company to file an ANDA. In 2010, the company began to market generic finished dosage products through Prinston Pharmaceutical Inc., which was spun off from Zhejiang Huahai Pharmaceutical Co., Ltd. in 2009. 

Subsidiaries of Zhejiang Huahai

Zhejiang Huahai Pharmaceuticals has a number of subsidiaries, including but not limted to: 

1. Huahai US Inc. 
2. Huahai (Japan) Pharm Co., Ltd. 
3. Shanghai SynCores Technologies
4. Prinbury Biopharm Co., Ltd. 
5. Shanghai Synergy Pharmaceuticals
6. Shanghai Huaao Biopharm Co., Ltd. 
7. Changxing Pharmaceutical Co., Ltd. 
8. Jiangsu Galaxy Imp. and Exp., Co., Ltd.  

Popular Products of Zhejiang Huahai

Zhejiang Huahai’s most popular products, with their therapeutic areas, are the following:

1. Ambrisentan – Anti-hypertensive
2. Apixaban – Anti-thrombotic
3. Aripiprazole – Anti-psychotic
4. Benazepril HCl – ACE Inhibitor
5. Canagliflozin – Anti-diabetic
6. Candesartan Cilexetil – Angiotensin II Receptor Antagonist
7. Captopril – ACE Inhibitor
8. Carvedilol – Anti-Hypertensive
9. Citalopram Hydrobromide – Anti-depressant
10. Clofazimine – Leprosy
11. Dabigatran etexilate – Anti-thrombonic
12. Dimethyl Fumarate – Multiple sclerosis
13. Donepezil HCl – Alzheimer’s disease
14. Duloxetine hydrochloride – Anti-depressant
15. Enalapril Maleate – ACE Inhibitor
16. Eprosartan mesylate – Angiotensin II Receptor Antagonist
17. Escitalopram Oxalate – Anti-depressant
18. Febuxostat – Chronic Gout drug
19. Fosinopril sodium – ACE Inhibitor
20. Irbesartan – Angiotensin II Receptor Antagonist 
21. Ketotifen hydrogen fumarate – Anti-histaminic
22. Lamotrigine – Anti-epileptic
23. Levetiracetam – Anti-epileptic
24. Levodopa – Anti-parkinsonian
25. Lisinopril – ACE Inhibitor
26. Losartan potassium – Angiotensin II Receptor Antagonist
27. Nebivolol – Anti-hypertensive
28. Nevirapine – Anti-AIDS
29. Olmesartan medoxomil –  Angiotensin II Receptor Antagonist
30. Paroxetine HCl, anhydrous – Anti-depressant 
31. Paroxetine HCl, Hemihydrate – Anti-depressant
32. Perindopril tert-butylamine – ACE Inhibitor
33. Pregabalin – Anti-epileptic
34. Quinapril Hydrochloride – ACE Inhibitor
35. Ramipril – ACE Inhibitor
36. Ranolazine – Anti-angina
37. Risperidone – Anti-psychotic
38. Rivaroxaban – Rivaroxaban
39. Rocuronium Bromide – Muscle Relaxants
40. Ropinirole Hydrochloride – Anti-parkinsonian
41. Silodosin – Benign Prostatic Hyperplasia
42. Sitagliptin – Anti-diabetic
43. Tadalafil – Erectile dysfunction
44. Telmisartan – Angiotensin II Receptor Antagonist
45. Temocapril Hydrochloride – ACE Inhibitor
46. Tolvaptan – Congestive heart failure
47. Torasemide – Diuretic
48. Valsartan – Angiotensin II Receptor Antagonist
49. Vildagliptin – Anti-diabetic
50. Voriconazole – Anti-fungal

Product Recalls and Lawsuits

1. In late 2018, the United States Food and Drug Administration (USFDA) issued a product recall and import ban for Zhejiang Huahai Pharmaceutical’s Valsartan blood pressure medicine. Huahai ran into trouble with the FDA and European regulators after it was discovered that the impurity N-nitrosodimethylamine (NDMA), a suspected cancer causing agent, had been showing up in its API, the result of a manufacturing change the drugmaker made years ago. While the levels of NDMA in Huahai’s valsartan API were trace amounts, they were considered unacceptable, the FDA has said. Further testing has also found N-Nitrosodiethylamine (NDEA), another suspected carcinogen, in the API. There are a number of class action lawsuits with regards to this issue, including Gotenski vs. Huahai and Kruk vs. Huahai, both in New Jersey, and Lewis vs. Huahai in Tennessee. 

Litigation Settlements

There are currently no public records of any litigation settlements entered into by Zhejiang Huahai. Settlements of its pending cases remain pending. 

Sources:

http://en.huahaipharm.com/ylzjy/index.aspx

https://www.todayonline.com/world/embattled-chinese-drug-maker-get-43-million-government-support

https://www.truthinadvertising.org/wp-content/uploads/2018/11/Lewis-v-Zhejiang-Huahai-Pharm-complaint.pdf

https://www.fiercepharma.com/manufacturing/china-s-zhejiang-huahai-lambasted-fda-warning-letter-for-putting-profits-ahead-safety

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm480035.htm

https://www.bloomberg.com/profiles/companies/ZHPHAZ:CH-zhejiang-pharmaceutical-co-ltd

Executive Summary

Teva pharmaceutical is a renowned leading pharmaceutical company in the world. It was established in 1901 and is located in Petah Tiqva Israel. 

It main focus is the development, production and marketing of generic branded pharmaceuticals and also the pharmaceutical ingredients. This company is among the top twenty pharmaceutical companies in the world and in the generic sector, it is among the top.

The company has also had its share of cases in the lawsuits and currently there are much litigation filed by different people and organizations following their product issues and liabilities.

-The Valsartan lawsuits are still pending although some have been settled but others are ongoing litigations. These cases came about when the valsartan drugs which were used by patients before the recall and resulted to many reactions and consequences which made this people and organization plus the state to file lawsuits to follow up this matter. Up to now some cases are ongoing and have not been concluded.

History of Teva Pharmaceuticals

Teva pharmaceuticals began as a very small drug business which was focused in making the medicines to be more available close to the patients and homes plus hospitals. This slowly built up to a manufacturing plant and during the time of World War 2, it became the sole supplier of medical drugs to the whole country, the neighboring and even the British army that was based in the Middle East.

The company then grew expanding its territories in and out of Israel making it among the best pharmaceutical companies in the world up to date.

Subsidiaries of Teva Pharmaceuticals

1. Actavis pharmaceuticals 

This is a global generic company which is focused in acquiring, developing, manufacturing and finally marketing of branded pharmaceuticals both over the counter and generic medicinal products. 

In May 2017, Teva pharmaceuticals acquired Actavis pharmaceuticals at a cost of $40 billion. The company is located in New Jersey United States.

The major areas of Actavis pharmaceuticals include; the eye care, medical aesthetics, central nervous system and gastroenterology.

The company itself is a long sequence of mergers and acquisitions.

1. Cephalon Inc

This company was established in 1987 and it is located in Pennsylvania, United States. In May 2011, Teva pharmaceuticals acquired Cephalon at a cost of $6.8 Billion and it became a whole subsidiary of Teva Pharma.

This company mainly focuses on therapies for cancer, inflammatory diseases and the central nervous system. It is dedicated to improving the lives of many people including patients all over the world through its developments and innovation in the medical industry.

1. Pliva

This is another subsidiary of Teva pharmaceuticals which is located in Zagreb, Croatia. It manufactures, and distributes generic drugs. It was established in 1921.

It is one of the largest pharmaceutical companies in Croatia. It was acquired at a cost of $2.2 billion in June 2006.

1. Mepha Pharma

It is an innovative pharmaceutical company which mainly focuses on developing, manufacturing and distributing branded and non branded generic products. It was established in 1949 and is based in Basel Switzerland. 

The company has done tremendous innovations in developing generics through new formulations or by using the drug delivery technology. Through this, it has provided very many additional benefits for the patients and the healthcare professionals.

The company was acquired in April 2010 by the Teva pharmaceutical company subsidiary Cephalon at a cost of $615 million.

1. Anda Inc

Anda Inc was established in 1992 and is located in Weston, Florida, United States. It is a wholesale distributor of pharmaceutical products in the US. It distributes generic products, vaccines, medical/surgical supplies, injectables and other products to pharmacies, hospitals and homes in the United States.

In August 2016, Teva pharmaceuticals acquired Anda Inc at a cost of $500 million deal. This made Anda Inc to be a whole subsidiary of Teva pharmaceuticals.

Popular Products of Teva Pharmaceuticals

1. Prexxartan

Its generic name is called Valsartan. It the product produced by Teva pharmaceuticals, which is available in the dosage of tablets. It is also a cardiovascular agent under the therapeutic category or class.

Prexxartan is used alone or with other medicines to treat high blood pressure commonly called hypertension. High blood pressure in most cases when in the body tends to overwork the heart and the arteries so much. This if prolonged may cause the arteries and the heart not functioning properly. It also leads to stroke.

It is also used to treat heart failure in case of heart attack.  This medicine will not cure high blood pressure but will control it. Take as prescribed by the doctor.

1. EpiPen

Its generic name is Epinephrine Injection. This is a product under Teva pharmaceuticals and it is an injection which contains Epinephrine. Epinephrine on the other hand is the chemical whose work is to narrow blood vessels and widely opens airways in the lungs. This reduces much the risk of getting stroke through the high blood pressure.

EpiPen is used to treat severe allergic reactions commonly called Anaphylaxis to insect stings, food and other allergens. It is also used to treat exercise induced anaphylaxis.

This product mainly focuses on controlling the main effects of high blood pressure like stroke being the main one. It is used in adults and for children only those that have attained the weight of 7.5kg and above.

1. Actiq

This produced by Teva pharmaceuticals and its generic name is Fentanyl. It is used to treat breakthrough pain patients who are tolerant to opioids. It is mainly used in adults and not children because it has not been established. But for the children who are 16 years, use the lowest effective doses and for the shortest duration possible.

Its effects are life threatening respiratory depression, abuse and misuse and addiction can be very fatal. Also accidental exposure may lead to overdose.

Always use as per the doctors’ prescriptions to avoid over or under dosing.

1. Zanosar

This products’ generic name is Streptozocin which is also produced by Teva pharmaceuticals. It is used to treat pancreatic, endocrine and thyroid cancers in adults and not at all recommended for children.

It has some reactions which may be fatal and not friendly to the body. It may have renal dysfunction or the disease itself and not at all recommended for pregnant or nursing mother and children also. It should be administered strictly according to the prescription of the doctor to avoid over and under dosing.

1. Trisenox Rx

Its generic name is called Arsenic trioxide. It is used to treat lymphomas, leukemia and other hematologic cancers. It is used in the diagnosis of adults and for children it is not yet established.

It has a risk of life threatening or fatal differentiation syndrome and has also the risk of cardiac conduction abnormalities. It is supplied in single dose vials and should be used or taken as prescribed by the doctor. Its reaction signs include; fever, fatigue, cough, itching, rash and headache.

1. Qvar Redihaler Rx

Its generic name is called Beclomethasone HFA. This product is used as maintenance treatment of Asthma done as prophylactic therapy. It is highly limited to the relief of acute bronchospasm and should not be used for that case at all.

It is used for both adults and children but for children is supposed to be from the age of 4 years and above and not administered to children under the age of 4 years.

Do not exceed the recommended dosing which might lead to some local infections.

Product Recalls and Lawsuits

1. Prexxartan (Valsartan) Product Recall 2018

In November 2018, Teva pharmaceuticals made a voluntary recall of prexxartan product, a combination of blood pressure drug. This recall was done mainly in the United States due to the detection of a cancer causing impurity. 

Due to adverse reactions of the patients involved mainly from the United States which was the most affected, many lawsuits were filed for the same which are ongoing. This is because many patients who took this drug are suffering medicals consequences and others are at a very high risk of getting cancer.

Litigation Settlements

1. $135 Million Litigation Settlement over Fraud

In January 2019, Teva pharmaceuticals settled and paid $135 million to settle a lawsuit which was filed earlier by attorney general in the year 2005 in Illinois accusing it with other 46 pharmaceutical firms of inflating fraudulently wholesale prices of drugs which are used to calculate or formulate Medicare reimbursement rates.

Sources:

https://www.empr.com/manufacture/teva-pharmaceuticals/

https://www.drugs.com/epipen-auto-injector.html

https://www.tevapharm.com/about/history/

https://www.crunchbase.com/organization/teva-pharmaceutical-industries

 

Executive Summary

Mylan N.V., incorporated on July 7, 2014, is a global pharmaceutical company. The Company develops, licenses, manufactures, markets and distributes generic, brand name and over-the-counter (OTC) products in a range of dosage forms and therapeutic categories. It operates through three segments on a geographic basis, North America, Europe and Rest of World. The Company’s Cold-EEZE family of brands includes OTC cold remedies sold as lozenges, gummies, oral sprays, caplets, QuickMelts and oral liquid dose forms in the United States. 

The North America segment is primarily made up of its operations in the United States and Canada. The Europe segment is made up its operations in approximately 35 countries within the region. The Rest of World segment is primarily made up of its operations in India, Australia, Japan and New Zealand. Also included in the Rest of World segment are its operations in markets, which include countries in Africa (including South Africa), as well as Brazil and other countries throughout Asia and the Middle East. 

The Company conducts active pharmaceutical ingredient (API) business through Mylan Laboratories Limited (Mylan India). As of December 31, 2016, it offers product portfolios, including approximately 7,500 marketed products around the world, to customers in over 165 countries and territories. It operates a global vertically integrated manufacturing platform around the world and API operations. It also operates research and development (R&D) network that delivers product pipeline, including a range of dosage forms, therapeutic categories and biosimilars.

History of Mylan N.V.

Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz. In 1966 Mylan began manufacturing penicillin G tablets as well as vitamins and other dietary supplements.

Panoz left Mylan in 1969 and Puskar quit the company in 1973, as it grew and experienced financial difficulties. The board hired Roy McKnight as board chairman, who convinced Puskar to return in 1976.

Mylan discontinued operating as a contract manufacturing organization in 1980 and instead chose to market their products under their own “Mylan-labeled” brand.

From the 1980s to the 2010s, Mylan ventured into a number of acquisitions that has proven fruitful, including Meda, EpiPen, Matrix, and others. 

Currently, it is the second-largest provider of prescription medicine in the United States. 

Subsidiaries of Mylan

Mylan N.V. lists its subsidiaries as:

Mylan Pharmaceuticals Inc.	West Virginia
Mylan Technologies Inc.	West Virginia
Mylan Institutional Inc.	Illinois
Mylan LLC	Delaware
Mylan Caribe, Inc.	Vermont
Mylan International Holdings, Inc.	Vermont
MLRE LLC	Pennsylvania
Synerx Pharma, LLC	Pennsylvania
MP Air, Inc.	West Virginia
American Triumvirate Insurance Company	Vermont
Somerset Pharmaceuticals, Inc.	Delaware
Mylan Bertek Pharmaceuticals Inc.	Texas
Euro Mylan B.V.	Netherlands
MP Laboratories (Mauritius) Ltd.	Mauritius
Mylan Singapore Pte. Ltd.	Singapore
Mylan Pharmaceuticals ULC	Canada
QD Pharmaceuticals ULC	Canada
Mylan Australia Pty. Ltd.	Australia
Mylan Australia Holding Pty. Ltd.	Australia
Mylan Delaware Inc.	Delaware
Mylan Europe B.V.B.A.	Belgium
Mylan LHC Inc.	Delaware
Mylan Bermuda Ltd.	Bermuda
Mylan Luxembourg L1 S.C.S.	Luxembourg
Mylan Luxembourg L2 S.C.S.	Luxembourg
Mylan Luxembourg L3 S.C.S.	Luxembourg
Mylan Luxembourg L4 S.C.S.	Luxembourg
Mylan Luxembourg 1 S.a r.l.	Luxembourg
Mylan Luxembourg 2 S.a r.l.	Luxembourg
Mylan Luxembourg 3 S.a r.l.	Luxembourg
Mylan Luxembourg 4 S.a r.l.	Luxembourg
Mylan Luxembourg 5 S.a r.l.	Luxembourg
Mylan Luxembourg 6 S.a r.l.	Luxembourg
Mylan Luxembourg 7 S.a r.l.	Luxembourg
Mylan Luxembourg 8 S.a r.l.	Luxembourg
Mylan Luxembourg 9 S.a r.l.	Luxembourg
Mylan (Gibraltar) 1 Ltd.	Gibraltar
Mylan (Gibraltar) 2 Ltd.	Gibraltar
Mylan (Gibraltar) 3 Ltd.	Gibraltar
Mylan (Gibraltar) 4 Ltd.	Gibraltar
Mylan (Gibraltar) 5 Ltd.	Gibraltar
Mylan (Gibraltar) 6 Ltd.	Gibraltar
Mylan dura GmbH	Germany
Mylan S.A.S.	France
Mylan Generics France Holding S.A.S.	France
Mylan EMEA S.A.S.	France
Mylan FCT	France
Mylan, Lda	Portugal
Societe de Participation Pharmaceutique S.A.S.	France
Generics [U.K.] Ltd.	United Kingdom
Mylan Pharma UK Limited	United Kingdom
McDermott Laboratories Ltd.	Ireland
Mylan Investments Limited	Ireland
Bioniche Pharma Holdings Limited	Ireland
Bioniche Pharma Group Limited	Ireland
Bioniche Pharma (Canada) Ltd.	Canada
Mylan Institutional LLC	Illinois
Bioniche Pharma Acquisition Ltd.	Ireland
Bioniche Teoranta	Ireland
Mylan Ireland Limited	Ireland
Mylan B.V.	Netherlands
Arcana Arzneimittel GmbH	Austria
Mylan S.p.A.	Italy
Qualimed S.A.S.	France
Mylan Pharmaceuticals	Morocco
Generics Pharma Hellas E.P.E.	Greece
Mylan GmbH	Switzerland
Mylan Switzerland GmbH	Switzerland
Mylan B.V.B.A.	Belgium
Mylan Group B.V.	Netherlands
Mylan Netherlands B.V.	Netherlands
Xixia Pharmaceuticals (Pty) Ltd.	South Africa
Acepharm Ltd.	South Africa
SCP Pharmaceuticals (Pty) Ltd.	South Africa
Mylan (Proprietary) Limited	South Africa
Mylan Pharmaceuticals S.L.	Spain
Prasfarma Oncologicos S.L.	Spain
Scandinavian Pharmaceuticals-Generics AB	Sweden
Scandpharm Marketing AB	Sweden
Mylan OY	Finland
Mylan AB	Sweden
Mylan ApS	Denmark
Mylan Denmark ApS	Denmark
Mylan AS	Norway
Genpharm General Partner, Inc.	New York
Genpharm Limited Partner, Inc.	New York
Mylan Pharmaceuticals Private Limited	India
Mylan Laboratories India Private Limited	India
Mylan Seiyaku Ltd.	Japan
Alphapharm Pty. Ltd.	Australia
Mylan Australia 1 Pty. Ltd.	Australia
Mylan Australia 2 Pty. Ltd.	Australia
Mylan New Zealand Ltd.	New Zealand
Pacific Pharmaceuticals Ltd.	New Zealand
EMD, Inc.	Delaware
Dey, Inc.	Delaware
Dey Limited Partner, Inc.	Delaware
Dey Pharma, L.P.	Delaware
Mylan Special Investments LLC	Delaware
RCF 4 LLC	Delaware
Mylan Securitization LLC	Delaware
Mylan Sp. Z.o.o.	Poland
Mylan s.r.o.	Slovakia
Mylan d.o.o.	Slovenia
Mylan Pharmaceuticals spol s.r.o.	Czech Republic
Mylan kft	Hungary
Mylan Hungary kft	Hungary
Mylan LLC	Russian Federation
Mylan Pharmaceuticals LLC	Ukraine
Mylan Laboratories Limited	India
Matrix Laboratories B.V.	Netherlands
Matrix Laboratories B.V.B.A.	Belgium
Matrix Laboratories Singapore (Pte.) Ltd.	Singapore
Matrix Laboratories Inc.	Delaware
Matrix Pharma Group (Xiamen) Limited	People’s Republic of China
Xiamen Mchem Research & Development Co. Ltd.	People’s Republic of China
Jiangsu Matrix Pharmaceutical Chemical Ltd.	People’s Republic of China
Matrix Laboratories (Xiamen) Ltd.	People’s Republic of China
Xiamen Beacon Pharmaceutical Manufacturing Co. Ltd.	People’s Republic of China
Mylan (Taiwan) Limited	Taiwan Province of China
Astrix Laboratories Limited	India
Docpharma B.V.B.A.	Belgium
AB Medical PRS B.V.	Netherlands
Aktuapharma N.V.	Belgium
Apothecon B.V.	Netherlands
DAA Pharma S.A.	Switzerland
DCI Pharma S.A.	France
Docpharma Luxembourg S.a r.l.	Luxembourg
Farma 1 S.R.L.	Italy
Hospithera N.V.	Belgium

Popular Products of Mylan

The top products of Mylan NV are: 

1. Aerospan HFA (flunisolide) – inhaled corticosteroids
2. Avita (tretinoin) – topical acne agent
3. cholorthiazide – thiazide diuretics
4. daptomycin – antibiotic
5. EpiPen (epinephrine) – adrenergic bronchodilators, catecholamines, vasopressors
6. eprosartan – angiotensin receptor blockers
7. ibutilide – group III antiarrhythmics
8. rufinamide – dibenzazepine anticonvulsants

Product Recalls and Lawsuits

1. In late 2018, Mylan voluntary recalled its line of valsartan blood pressure drugs. This is due to the detection of trace amounts of N-Nitrodiethylamine (NDEA) impurities found in the drug. 

Litigation Settlements

1. In August 2017, the company formally agreed to pay $465 million to settle a federal lawsuit claiming it mischaracterized EpiPens as generic to avoid paying higher Medicaid rebates. At the time, it was one of the most expensive settlements in the United States. 

Sources:

https://www.reuters.com/finance/stocks/company-profile/MYL.O

http://investor.mylan.com/financial-information/sec-filings

http://investor.mylan.com/static-files/ed066de0-8491-4327-a044-9bb136d5b8c3

https://www.sec.gov/Archives/edgar/data/69499/000119312512070508/d258059dex21.htm

https://www.mylan.com/en/about-mylan

https://craft.co/mylan

https://www.drugs.com/manufacturer/mylan-pharmaceuticals-inc-93.html

https://www.fda.gov/Safety/Recalls/ucm627647.htm