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Mylan

 

Executive Summary

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

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

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

History of Mylan N.V.

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

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

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

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

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

Subsidiaries of Mylan

Mylan N.V. lists its subsidiaries as:

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

Popular Products of Mylan

The top products of Mylan NV are: 

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

Product Recalls and Lawsuits

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

Litigation Settlements

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

Sources:

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

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

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

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

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

https://craft.co/mylan

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

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

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.