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:
- Aerospan HFA (flunisolide) – inhaled corticosteroids
- Avita (tretinoin) – topical acne agent
- cholorthiazide – thiazide diuretics
- daptomycin – antibiotic
- EpiPen (epinephrine) – adrenergic bronchodilators, catecholamines, vasopressors
- eprosartan – angiotensin receptor blockers
- ibutilide – group III antiarrhythmics
- rufinamide – dibenzazepine anticonvulsants
Product Recalls and Lawsuits
- 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
- 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://www.drugs.com/manufacturer/mylan-pharmaceuticals-inc-93.html
https://www.fda.gov/Safety/Recalls/ucm627647.htm
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.