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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- AndroGel (Testosterone in gel) – AndroGel is a testosterone replacement therapy for males diagnosed with symptomatic low testosterone due to certain underlying conditions.
- 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
- 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.
- 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.
- 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
- AbbVie’s Zemplar injection was recalled in 2015 because a single vial contained free floating glass particles.
- In 2013, AbbVie’s Synthroid had to be recalled because of a labelling error.
Litigation Settlements
- 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.
- 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
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.