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:

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

Executive Summary

Janssen pharmaceutical is a pharmaceutical company which is located in Belgium and its headquarters is in Beerse, Antwerp, Belgium. Janssen provides medicines in many areas in the health sector and several therapeutic areas.

The company also focuses on conducting great and deeper research in many different areas including neurological disorders, mental illness, oncology, allergies, fungal infections and gastrointestinal disorders.

In its development, manufacturing and distribution of its products, Janssen has had issues with various organizations, people and also the state over its products’ liabilities and has faced many lawsuits of which some have been settled and some have not been settled yet. 

-New Jersey Lawsuit about Opioids;

The state of New Jersey filed a lawsuit against Janssen Pharmaceuticals Company in November 2018. The state accused the company of minimizing or hiding the risks posed by opioid addiction when it was marketing the opioids targeting older people and other patients who had very little knowledge of opioids. This accusation led to this litigation and still the lawsuit is still on where no settlement has actually been reach or any compensation.

History of Janssen Pharmaceuticals

Janssen Pharmaceutical was established in 1953 by a Belgium researcher called Dr. Paul Janssen. He then established a research laboratory called Janssen pharmaceutica where he started doing his research for many therapies and medicines.

Dr. Janssen’s research laid quite a great foundation for over 80 medicines currently manufactured and developed by the company in saving many lives in the world today.

In 1961, Janssen pharmaceuticals joined Johnson & Johnson Company which is a pharmaceutical company as a subsidiary. It continued to search for solutions to change peoples’ lives.

In 1988, Janssen pharmaceuticals in Australia joined with Cilag, also another research company in chemical biotechnology. These two companies have highly joined forces and have spread widely all over the world and now they are called Janssen.

Subsidiaries of Janssen Pharmaceuticals

1. XO1 Limited

Janssen pharmaceuticals acquired Xo1 limited in March 2015. Xo1 limited is a privately owned biopharmaceutical company which was founded in order to help in developing the anti-thrombin antibody ichorcumab.

Ichorcumab is the human antibody which is developed to mimic the activities of the human antibody which produces ant coagulated state without necessary predispositioning to bleeding.

1. Corimmun

It is a drug development company that majorly focuses on therapeutics and heart diagnostics and vascular diseases. The company is located in Bayern Germany.

Janssen acquired Corimmun Company in July 2012. The company will help a lot in the areas of the heart and other vascular disorders or problems.

This acquisition shows that Janssen pharmaceuticals are highly committed to invest highly in the area of science specifically in the areas of great or urgent medical need. This ensures that new therapies are designed to improve the patience needs and also the lives of people all over the world.

Popular Products of Janssen Pharmaceuticals

1. Risperdal

Its generic name is called Risperidone. It is an antipsychotic medicine which mainly works by changing the chemicals in the human brain. It is mainly used to treat schizophrenia in both adults and children but children who are over 13 years old. 

This medicine is also used to treat the bipolar disorder symptoms in adults and children above 10 years old.

The medicine has some side effects and when you encounter them then consult the doctor e.g. difficulty breathing, swelling of your tongue, face and throat.

1. Nizoral Topical

Its generic name is called ketoconazole topical. It meant for the skin and it is antifungal drug used to treat infections such as dandruff, ringworm and athlete’s foot.

It is also used to treat pityriasis which is a fungal infection causing scaly discolored skin patches mostly on the chest, neck, legs or arms.

It should be used exactly as the prescription of the doctor and always wash your hands before and after using this medicine.

Its side effects mostly include thinning hair, shortness of breath, mild itching.

1. Prezcobix

Its generic name is called Cobicistat and darunavir. It contains a combination of darunavir and cobicistat where Darunavir is an antiviral medicine which prevents human immunodeficiency virus (HIV) from getting multiplied in the human body. Cobicistat on the other hand reduces the action of the enzymes in the liver that are used to break down some antiviral medicines.

With other medicines, it works well to treat HIV in adults, the virus that causes AIDS. It is not a cure for AIDS.

It should be used exactly as it was described by the doctor and should always be taken with food. Ensure frequent medical tests when using this medicine.

1. Elmiron

This is another product of Janssen pharmaceuticals. Its generic name is called pentosan polysulfate sodium. This medicine works like a blood thinner that is used to prevent blood clotting. It is also used to treat bladder pain and discomfort.

This medicine should be taken on an empty stomach at least 1 hour before any meal or 2 hours after having a meal.

Use this medicine as recommended by the doctor and do not use it for longer or shorter as prescribed by the doctor. Always check for certain effects when using this drug.

1. Axert

Its generic name is also called Almotriptan. This is used for the treatment of headache. It narrows the blood vessels around the brain and reduces certain substances in the body that can always trigger headache pain and nausea.

It is used to treat headaches which are migraine in adults and children or adolescents who are 12 years old. It always treats headache that has always began and cannot prevent any headache from occurring or happening.

1. Darzalex

The generic name for this product is called Daratumumab. It is a monoclonal antibody that is being used to block certain protein in the body that affects tumor cell growth. These antibodies are produced and only to target and destroy certain cells in the body.

It is also used to treat bone marrow cancer where it is usually given after all other treatments having failed totally to function.

Its common side effects includes; shortness of breath, fever, swelling in your hands or feet, trouble getting a sleep.

This medicine is given as an infusion into the vein. You will need frequent medical tests and it can affect the blood typing tests up to at least 6 months after stopping to take this medication.

1. Xarelto

It generic name is Rivaroxaban. This medicine is used to treat a blood clotting type called Deep Vein Thrombosis (DVT) which can easily lead to blood clotting in the lungs.

It is used in people with a heart rhythm disorder so that it can lower the risk of stroke which the blood clotting can cause. It is also given together with aspirin to lower the risk of serious heart problems, stroke and heart attack.

You should not use this medicine if you have; a bleeding disorder, uncontrolled high blood pressure, stomach or intestinal bleeding or ulcers and hemorrhagic stroke.

Take this medicine as prescribed by the doctor and do not over or under dose.

Product Recalls of Janssen Pharmaceuticals

1. 2018 Ortho – Novum Recall

Janssen pharmaceuticals issued a voluntary recall of Ortho – Novum in November 2018. This recall was due to incorrect veridate instructions. This recall was up to the pharmacy level. The patient information which was provided inside did not at all include the appropriate of the required information or instructions for the veridate dispenser.

The major risk that was involved in taking Ortho – Novum without using the clear guidelines and instructions for the correct use is that the affected patient could take the pills in the manner in which is not correct which could result in breakthrough bleeding and pregnancy which is not intended.

The Ortho – Novum pills are mainly used in the prevention of pregnancy for those who prefer to use these pills as the method of preventing pregnancy or as contraceptive.

The Ortho – Novum itself was very safe with the right instructions inside. This recall only affected the distribution in the US. No lawsuit has been filed concerning this recall yet and no adverse reactions have been reported so far.

1. 2013 Risperdal Consta Recall

Janssen pharmaceuticals made a recall in September 2013 for Risperdal Consta, a product they manufacture. This recall was aimed at wholesalers, distributors, health providers and pharmacies.

This medicine is an anti-psychotic medication which is mainly used to treat bipolar disorder and schizophrenia. Unlike the Risperdal basic pill, it is injected.

This recall was made after discovering a mold during the routine checking and testing processes. This prompted the company to make this recall. 

Since this recall, there has not been any complain or lawsuit filed concerning this recall and the reactions thereafter of any effects of this mold.

Janssen Pharmaceuticals Settlements

1. Xarelto Litigation settlement

In March 2019, Janssen pharmaceuticals together with Bayer pharmaceuticals settled $775 million over Xarelto claims and lawsuits. This case came about after patients who were affected sued the drug makers over failure to warn patients of the danger the drug would cause of bleeding episodes.

This settlement put to an end over 25,000 lawsuits by the state and the federal claims that surrounded this issue.

1. Montana $5.9 Settlement

In March 2014, Janssen agreed to pay and settle a claim that was filed by Montana physicians for an amount of $5.9 million.

In this case, the company was accused of employing illegal and deceptive means in the marketing of antipsychotic drug Risperdal. The suit alleged that Janssen highly deceived consumers and Montana that the product is very safe and quite effective for various conditions.

The company agreed to settle the case for $5.9 million but did not admit any liability or wrongdoing.

Sources:

https://www.crunchbase.com/organization/janssen-pharmaceuticalshttps://www.janssen.com/australia/about-us/our-historyhttps://www.fda.gov/Safety/Recalls/ucm625012.html

https://www.drugs.com/manufacturer/janssen-pharmaceuticals-inc-74.html

Executive Summary

Mitsubishi Tanabe Pharma Corporation is a Japanese pharmaceuticals company, a subsidiary of Mitsubishi Chemical Holdings Corporation. It is a Japan-based company mainly engaged in the manufacture and sale of pharmaceutical products. The medical supplies business is engaged in the research, development, manufacture and sale of ethical pharmaceutical and non-prescription drugs. The Company’s subsidiaries receive raw materials from the company and sell products locally.

History of Mitsubishi Tanabe Pharma

Takeda Kasei Co., Ltd. was established in 1940 by Chobei Takeda & Co., Ltd. (present-day Takeda Pharmaceutical Company) and Nippon Kasei Chemical Co. Ltd. (present-day Mitsubishi Chemical Corporation) and built its first plant in Higashi-Yoshitomi-mura, Fukuoka Prefecture. The company changed its name in 1952 to Yoshitomi Pharmaceutical Co., Ltd. in 1946 and listed on Tokyo and Osaka stock exchanges in 1949.

The Blood Plasma Corporation of Japan was established in 1950 with head office and plant in Osaka. This company changed its name to Green Cross Corporation in 1964.

Green Cross Corporation was acquired by Yoshitomi Pharmaceutical in 1998, changing its name to Welfide Corporation in 2000. The founders of Green Cross Corporation included war criminals such as Kitano Masaji who performed torture and experimentations on humans in the Japanese military’s notorious Unit 731 during World War II. These crimes were recognized by the UN as extreme “crimes against humanity”.

In 1901 Motosaburo Tanabe established a pharmacy in Tokyo, which was incorporated in 1921 as Motosaburo Tanabe Shoten, changing its name in 1943 to Tokyo Tanabe Pharmaceuticals Co., Ltd.

Nippon Tar Industries was established in 1921, becoming Mitsubishi Chemical Industries, Ltd. in 1952. This company established a business alliance with Tokyo Tanabe Pharmaceuticals Co. in 1981, and changed its name to Mitsubishi Chemical Corporation following the 1984 merger with Mitsubishi Petrochemical Co., Ltd.

Mitsubishi Chemical Corporation and Tokyo Tanabe Pharmaceuticals Co. merged formally in 1999 and formed Mitsubishi-Tokyo Pharmaceuticals, Inc., to take over the combined pharmaceutical operations of the two companies.

Mitsubishi-Tokyo Pharmaceuticals and Welfide Corporation merged in 2001 to establish Mitsubishi Pharma Corporation, and this company joined again with Mitsubishi Chemical Corporation to create Mitsubishi Chemical Holdings Corporation in October 2005. In 2007, Mitsubishi Tanabe Pharma was born out of the merger between Tanabe Seiyaku and Mitsubishi Pharma.

In August 2014 the company announced it had agreed to collaborate with AstraZeneca to leverage the pair’s strengths, expertise and assets on diabetic nephropathy, in a bid to develop high quality drugs much quicker than working alone. According to the National Institute of Health, 60% to 70% of diabetic sufferers in the U.S. alone suffered from nerve disorders related to diabetic nephropathy. The three-year research agreement has the objective of creating new treatments to replace expensive and limited options currently in place, mainly being dialysis or kidney transplantation.

In July, 2017, the company acquired Neuroderm for $1.1 billion.

Subsidiaries of Mitsubishi Tanabe Pharma:

Among Mitsubishi Tanabe Pharma’s notable subsidiaries are:

• Yoshitomiyakuhin Corporation – Japan
• Mitsubishi Tanabe Pharma Factory Ltd. – Japan
• Tanabe Seiyaku Yoshiki Factory Co., Ltd. – Japan
• Mitsubishi Tanabe Pharma Holdings America, Inc. – USA 
• MP Healthcare Venture Management Inc. – USA
• Medicago Inc. – Canada
• Tianjin Tanabe Seiyaku Co., Ltd. – Asia
• NeuroDerm Ltd. – Europe

A full list of subsidiaries may be found here: https://www.mt-pharma.co.jp/e/ir/annual/pdf/CR_2018_en.pdf

Popular Pharmaceutical Products of Mitsubishi Tanabe Pharma

The top products of Mitsubishi Tanabe Pharma

1. Remicade – Treatment of rheumatoid arthritis (RA), Crohn’s disease, psoriasis, ulcerative colitis, Behcet’s disease with refractory uveoretinitis, and ankylosing spondylitis
2. Talion – Treatment of allergic disorders 
3. Maintate – Treatment of hypertension, angina pectoris, extrasystole, chronic heart failure, and atrial fibrillation
4. Kremezin – Treatment of chronic kidney disease
5. Tetrabik – Combined vaccine for diphtheria, pertussis, tetanus, and polio
6. Varicella vaccine – Freeze dried live attenuated varicella vaccine 

Product Recalls and Lawsuits

1. In 2011, Mitsubish Tanabe Corp recalled two million of its injectable medicines made at a facility in Ashikaga, Japan, because it cannot guarantee their quality. The products that were affected were 5mcg and 10mcg formulations of the arteriosclerosis treatment Liple (alprostadil); 2.5mg doses of corticosteroid Limethason Intravenous Injection (dexamethasone palmitate) used to treat rheumatoid arthritis; and 300mg and 500mg doses of the quinolone antibiotic Pazucross Injection (pazufloxacin mesylate).

Litigation Settlements

As of 2019, Mitsubishi Tanabe has not been involved in any remarkable litigation settlements. 

Sources:

https://www.mt-pharma.co.jp/e/ir/annual/pdf/CR_2018_en.pdf

https://www.mt-pharma.co.jp/shared/show.php?url=/e/ir/annual/index.html

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

http://www.pharmafile.com/news/280111/mitsubishi-tanabe-recalls-two-million-injectables

https://www.mt-pharma.co.jp/shared/show.php?url=/e/ir/annual/index.html

Executive summary

Allergan is a global pharmaceutical company which is located in Dublin Ireland and also its headquarters are located there. It is mainly focused on developing, manufacturing and distributing pharmaceutical, regenerative medicine products, surgical, biological products plus healthcare devices.

The markets quite a range of its own products and leading brands in many areas which includes; urology, women’s health, medical aesthetics and dermatology, gastroenterology, eye care and the central nervous system.

The company is an open science leader which has helped it so much in developing game changing ideas and innovations for the better and great care of the patients. It has over 100 operations globally and dedicated in working with healthcare providers and physicians in delivering meaningful and very innovative treatments to support and help people around the world to have healthier and longer lives.

Allergan pharmaceuticals in its operation, has received a share of litigations and lawsuits concerning its products. A lawsuit currently in place includes;

• Los Angeles lawsuit against Seri Scaffold surgical mesh

In November 2016, a Los Angeles woman sued the company over its conspiracy with a doctor to promote the use of Seri Scaffold surgical mesh and Natrelle breast tissue in an experimental manner without her knowledge and consent. She sued the company for fraud, negligence and failure to warn her of the consequences and that Seri Scaffold surgical mesh did not receive clearance from FDA for use in breast cancer reconstruction. She is seeking punitive damages for the case. 

History of Allergan pharmaceuticals

Allergan was established in 1948 by Gavin S. Herbert a pharmacist and Dr. Parmis Khatibi. They created the first drug which was an allergy nose drop in Los Angeles and was marketed using the name Allergan. This eye drops then propelled the company to the eye care field from then henceforth.

The Allergan pharmaceuticals became a company in 1950 officially and it focused more on the eye care and eye care products by then being under private and became public in the year 1970. 

In 1980, the company merged with Smithkline Beckman which lasted for 9 years and in 1989, the two companies separated and which afterward was acquired by Smithkline Beecham.

Allergan has been involved in making major treatments falling under the umbrella of eye care, neuroscience and medical aesthetics. It has been involved in major acquisitions and expanding its base in the pharmaceutical industry globally.

Subsidiaries of Allergan pharmaceuticals

1. Zeltiq Aesthetics

In March 2017, Allergan pharmaceuticals acquired Zeltiq aesthetics at a cost of $2.5 billion for complete acquire becoming part of Allergan family.

Zeltiq Aesthetics is a company which was established in 2005 and is located in California United States.

It is a science based company which deals with medical devices in developing the non-evasive procedures focusing mostly on reducing the unwanted body fat tissues.

1. Envy Medical Inc.

This is the latest acquire of Allergan. It was acquired in March 2019 at an undisclosed fee. This company was established in 2002. It is a biotechnology company which provides dermatology plus medical aesthetics solutions.

The company is mostly involved in skin therapy which delivers in excellent skin health and appearance to address the issues of skin concerns. It has well perfected this area of skin therapy through Dermalinfusion which is the skin resurfacing treatment.

1. Bonti

Allergan acquired Bonti in September at a cost of $195 million. The company was established in 2015. It was formerly called Endurance Biotech and changed this name to Bonti in 2015. It is a biotechnology company based in California United States.

1. Elastagen

Elastagen is a company based in Sydney, New south Wales, Australia and was established in the year 2003. It was acquired by Allergan pharmaceuticals in February 2018 at a cost of $95 million.

This company focuses on treatment of the skin and offers solution to the skin care health. It is a medical company with products based on the human protein tropoelastin. Its technology platform has potentials in focusing many areas which includes; scar remodeling, skin rejuvenation and repair of tissues.

1. Tobira Therapeutics

Tobira therapeutics is a company which is mostly engaged in the research and developing of compounds used for treating life threatening and very infectious diseases or ailments. It is located in New Jersey, United States. The company was established in 2006.

In September 2016, Tobira therapeutics was acquired by Allergan pharmaceuticals at a cost of $1.7 billion. This made the company to become whole subsidiary of Allergan.

The life threatening diseases which this company is involved are like HIV/AIDS, hepatitis and other infectious conditions.

1. Chase pharmaceuticals

Chase pharmaceutical is a company which is focused in medical clinical developments of improved treatments for the central nervous system. It is located in Washington, United States. It was established in the year 2007.

It was acquired by Allergan pharmaceuticals in November 2016 at a cost of $125 million.

1. Motus Therapeutics

Motus therapeutics is a company which is involved in the treatment of metabolic diseases. It is located in Boston, Massachusetts, United States and was established in 2008.

The company was acquired by Allergan pharmaceuticals in October 2016 at a cost of $200 million making it a whole subsidiary of Allergan pharmaceuticals.

1. Forest Laboratories Holdings

In November 2014, Allergan pharmaceuticals acquired Forest Laboratories at accost of $66 billion. The company was established in 1992 and is based in Dublin Ireland.

This company focuses on developing, discovering and researching the therapeutics and pharmaceutical drugs for the unmet needs of patients all over the world.

Popular products of Allergan pharmaceuticals

1. Celexa

Its generic name is Citalopram. 

It belongs to the class of antidepressant agents which is widely used in the treatment of depression symptoms. It is always used in the treatment of depression as indicated in the label and is not also limited to the treatment of post stroke behaviors, ethanol abuse and sexual dysfunction and in children used for OCD (Obsessive compulsive disorder).

1. Botox

Its generic name is called Botulinum toxin type A.

It is used to treat neck pains and abnormal head position which are associated with cervical dystonia. Also used to temporarily treat the appearance of moderate frown lines between the eyebrows and treatment of excessive underarm sweating.

1. Lexapro

Its generic name is Escitalopram.

It is mostly used for major depressive disorder (MDD) and generalized anxiety disorder (GAD).

1. Viberzi

Its generic name is called Eluxadoline

It is used for the treatment of irritable bowel syndrome with diarrhea.

1. Linzess

Its generic name is called Linaclotide

It is orally administered. It is used to treat irritable bowel syndrome with constipation and chronic constipation.

1. Dalvance

The generic name for this product is Dalbavancin.

Dalvance for injection is used to treat adult patients with bacterial skin infections.

1. Fetzima

The generic name for this product is called Levomilnacipran.

It is used in the treatment of major depressive disorder (MDD).

Product Recalls and Lawsuits

1. Taytulla 2018 Recall

In May 2018, Allergan pharmaceuticals made a recall for Taytulla, a birth control pill. The reason for the recall was due to the packaging error which could result in one getting pregnant.

The four placebo capsules were placed out of order and this meant that patients could receive four non hormonal capsules for the first four days of the therapy instead of the active pink capsules which should be taken as one daily and the followed by four maroon capsules up to the end of the month.

After this recall, some lawsuits were filed against the company for damages caused after using the drug with the wrong instructions. 

1. 2015 Refresh Lacri-Lube, Refresh P.M., FML, Blephamide Recall

Allergen Pharmaceuticals issued a voluntary recall in August 2015 of Refresh Lacri-Lube, Refresh P.M., FML, Blephamide due to potential contamination that could result to eye pain, swelling, irritation and ocular discomfort.

This recall was initiated by the company receiving complaints from customers of a small black particle contained in the drug which made the company to make this immediate and voluntary recall of the lots affected. This was in the interest of patient safety.

Litigation Settlements

1. $600 Million Botox Settlement

In September 2010, Allergan pharmaceuticals paid $600 million in settlement of charges that it promoted and sold illegally it Botox drug from the year 2005 for unapproved uses.

The government trough a civil case alleged that the company with vigor and without thought of the negative effects health wise illegally promoted this drug Botox for uses that were not deemed safe by FDA.

The company developed and put a vigorous marketing strategy program and even included paying kickbacks to doctors who prescribed this drug for the unapproved uses.

Allergan agreed to pay $375 million to the government for one criminal charge it pleaded guilty to and $225 million to be submitted to Medicaid, Medicare and other government programs for civil charges of causing false claims.

1. $313million  Celexa marketing claim Settlement 

In September 2010, Forest laboratories (now part of Allergan) the maker of Celexa paid $313 million to settle criminal and civil charges against it. It was alleged that the company drug for use in children for uses that were not yet approved by the FDA.

The company between the year 2000 and 2005 promoted and marketed the drug Celexa for uses which included cerebral palsy in children and headache instead the drug was approved for adult depression.

Sources:

https://www.allergan.com/about/company-profile

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

https://www.nytimes.com/2010/09/16/health/16drug.html

https://www.crunchbase.com/organization/allergan/acquisitions/acquisitions_list#section-acquisitions

https://www.drugbank.ca/drugs/DB00083