Previous company name
MYLAN LABORATORIES INC.
Name change date
Mylan Laboratories Inc. is a leading pharmaceutical company which specializes in developing, manufacturing and marketing generic pharmaceuticals. The company is one of the world’s leading manufacturers of prescription medicines overall, with more than 140 generic products in approximately 360 product strengths, covering more than 40 therapeutic areas. In 1961, it was founded as Milan Pharmaceuticals Inc. by Milan Mike Puskar and Don Panoz in White Sulphur Springs, W.Va., as a pharmaceutical distribution company. The company’s corporate headquarters is located in Canonsburg, Pennsylvania in the United States of America.
Mylan Laboratories Inc. is a global pharmaceutical company with market leading positions in generic pharmaceuticals, transdermal technology and unit dose packaged products. The company focuses on providing an extensive line of prescription drugs in traditional and innovative dosage forms, and it enjoys a well-deserved reputation for scientific expertise in creating difficult-to-formulate and high-barrier-to-entry generic products.
Mylan Laboratories Inc. operates through three principal subsidiaries: Mylan Pharmaceuticals Inc., a world leader in the research, development, production and marketing of generic pharmaceuticals; Mylan Technologies Inc., a leader in transdermal drug delivery technology and is the largest producer of generic and branded transdermal patches for the US market; and UDL Laboratories Inc., the top US-supplier of unit dose pharmaceuticals to hospitals and other institutions.
Mylan Laboratories Inc. also owns a controlling interest in India-based Matrix Laboratories Limited, which provides the company with a platform for global expansion and growth. Matrix is the second largest supplier of active pharmaceutical ingredients (API) sourcing and provides expanded marketing capabilities through Docpharma, a Matrix subsidiary that is a primary marketer of branded generics in Europe.
Mylan Inc. (Mylan) is a global pharmaceutical company that develops, licenses, manufactures, markets and distributes generic and branded generic pharmaceuticals, specialty pharmaceuticals and active pharmaceutical ingredients (APIs). It operates through two business segments: Generics and Specialty. The Generics Segment primarily develops, manufactures, sells and distributes generic or branded generic pharmaceutical products in tablet, capsule or transdermal patch form, as well as API. The Specialty Segment engages mainly in the manufacture and sale of branded specialty nebulized and injectable products. As of December 31, 2009, Mylan marketed more than 900 different products covering an array of therapeutic categories to consumers in more than 140 countries and territories across the globe. During the year ended December 31, 2009, the Company acquired approximately 25% of the remaining interest in Matrix Laboratories Limited, bringing both its total ownership and control to over 96%.
Description and history
Mylan Inc. (Mylan), incorporated in 1970, is a global pharmaceutical company that develops, licenses, manufactures, markets and distributes generic and branded generic pharmaceuticals, specialty pharmaceuticals and active pharmaceutical ingredients (APIs). The Company operates through two business segments: Generics and Specialty. The Generics Segment primarily develops, manufactures, sells and distributes generic or branded generic pharmaceutical products in tablet, capsule or transdermal patch form, as well as API. The Specialty Segment engages mainly in the manufacture and sale of branded specialty nebulized and injectable products. As of December 31, 2009, Mylan marketed more than 900 different products covering an array of therapeutic categories to consumers in more than 140 countries and territories across the globe. During the year ended December 31, 2009, the Company acquired approximately 25% of the remaining interest in Matrix Laboratories Limited (Matrix), bringing both its total ownership and control to over 96%. In September 2010, the Company acquired Bioniche Pharma Holdings Limited, an injectable pharmaceutical company.
The Company’s generic pharmaceutical business is conducted primarily in the United States and Canada (collectively, North America); Europe, the Middle East and Africa (collectively, EMEA), and Australia, India, Japan and New Zealand (collectively, Asia Pacific). Its API business is conducted through its Indian subsidiary, Matrix, which is included within the Asia Pacific region in the Company’s Generics Segment. It offer a range of dosage forms and delivery systems, including oral solids, topicals, liquids and semi solids, as well as high-potency formulations, steriles, injectables, transdermal patches, controlled release and respiratory delivery products. The Company obtains generic products primarily through internal product development. In addition, it licenses or co-develops products through arrangements with other companies. During the year ended December 31, 2009, Mylan received 593 product approvals globally. Of that total, 43 were in the United States, six in Canada, 45 in Asia Pacific, 386 in EMEA, nine from the World Health Organization (WHO) and 104 approvals for anti-retroviral (ARV) products. The 43 approvals in the United States consisted of 26 final Abbreviated New Drug Application (ANDA) approvals and 17 tentative ANDA approvals. During 2009, it completed 905 submissions globally, which included 91 in North America, 649 in EMEA and 165 in Asia Pacific. These submissions included those for existing products in new markets, as well as products new to the Mylan portfolio.
The Company’s sales are derived principally through Mylan Pharmaceuticals Inc. (MPI) and UDL Laboratories, Inc. (UDL), its wholly owned subsidiaries. MPI is Mylan’s primary United States pharmaceutical research, development, manufacturing, marketing and distribution subsidiary. MPI’s net revenues are derived primarily from the sale of solid oral dosage products. In addition, MPI also derives net revenues through transdermal patch products that are developed and manufactured by Mylan Technologies, Inc. (MTI), the Company’s wholly owned transdermal technology subsidiary. UDL primarily re-packages and markets products either obtained from MPI or purchased from third parties, in unit dose formats, for use primarily in hospitals and other medical institutions.
In the United States, the Company’s product portfolio consists of approximately 224 products, of which approximately 206 are in capsule or tablet form in an aggregate of approximately 532 dosage strengths. Included in these totals are 25 extended release products in a total of 61 dosage strengths. In addition to those products that the Company manufactures in the United States, it also markets, principally through UDL, 50 generic products in a total of 102 dosage strengths under supply and distribution agreements with other pharmaceutical companies. Its United States product portfolio also includes three transdermal patch products in a total of 15 dosage strengths that are developed and manufactured by MTI. MTI’s fentanyl transdermal system (fentanyl) is a generic class II narcotic transdermal product.
Through Mylan Pharmaceuticals ULC, a wholly owned subsidiary, the Company manufactures and markets generic pharmaceuticals in Canada. Mylan Pharmaceuticals ULC offers a portfolio of approximately 120 products, in an aggregate of approximately 260 dosage strengths. The Company’s generic pharmaceutical sales in EMEA are generated primarily by its wholly owned subsidiaries in Europe. Mylan has operations in 25 countries. In France, the Company markets through its subsidiaries, Mylan S.A.S. and Qualimed S.A.S., a portfolio of approximately 160 products, in an aggregate of approximately 310 dosage strengths. In Italy, Mylan markets through its subsidiary, Mylan S.p.A., a portfolio of approximately 110 products, in an aggregate of approximately 210 dosage strengths.
In Spain, the Company markets through its subsidiary, Mylan Pharmaceuticals S.L., a portfolio of approximately 80 products, in an aggregate of approximately 190 dosage strengths. In Germany, Mylan markets through its subsidiary, Mylan dura, a portfolio of approximately 160 products, in an aggregate of approximately 830 dosage strengths. In the United Kingdom, the Company offers a product portfolio of approximately 170 products, in an aggregate of approximately 380 dosage strengths. The Company also operates in Sweden, Ireland, Poland, Hungary, Slovakia, Slovenia and the Czech Republic. In addition, it has an export business, which is focused on Africa and the Middle East. The Company markets generic pharmaceuticals in Asia Pacific through wholly owned subsidiaries in Australia, New Zealand, India and Japan. In addition, it markets APIs to third parties, as well as to other Mylan subsidiaries through Matrix.
Alphapharm Pty. Ltd., the Company’s Australian subsidiary, supplies prescription pharmaceuticals in Australia, and offers approximately 160 products, in an aggregate of approximately 350 dosage strengths. In New Zealand, the Company operates through its subsidiary, Mylan New Zealand Ltd. Mylan Seiyaku Ltd., the Company’s Japanese subsidiary, offers a portfolio of approximately 470 products, in an aggregate of approximately 830 dosage strengths. It has a manufacturing facility located in Japan. In India, the Company conducts its business through Matrix. Through Matrix, Mylan manufactures and supplies API for the Company’s own products and pipeline, as well as for third parties. Matrix also supplies API for the manufacturing of ARV drugs, which are utilized in the treatment of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). In addition, Matrix offers a line of finished dosage form (FDF) products in both the ARV and non-ARV markets. As of December 31, 2009, Mylan had more than 200 APIs in the market or under development. The Company produces API for use in the manufacture of Mylan’s pharmaceutical products, as well as for use by third parties, in a range of categories, including anti-bacterials, central nervous system agents, anti-histamine/anti-asthmatics, cardiovasculars, anti-virals, anti-diabetics, anti-fungals, proton pump inhibitors and pain management drugs.
In North America, the Company markets products directly to wholesalers, distributors, retail pharmacy chains, mail order pharmacies and group purchasing organizations. It also markets its generic products indirectly to independent pharmacies, managed care organizations, hospitals, nursing homes, pharmacy benefit management companies and government entities. These customers, called indirect customers, purchase the Company’s products primarily through its wholesale customers. In EMEA and Asia Pacific, generic pharmaceuticals are sold to wholesalers, independent pharmacies, and in certain countries, directly to hospitals. Its APIs are sold primarily to generic FDF manufacturers worldwide, as well as to other Mylan subsidiaries.
The Company’s specialty pharmaceutical business is conducted by Dey Pharma, L.P. (Dey). Dey’s products are primarily branded specialty nebulized, injectable and transdermal products for life-threatening conditions. Dey offers the EpiPen auto-injector, which is used in the treatment of severe allergies, and is an epinephrine auto-injector. Dey has worldwide rights to the epinephrine auto-injector supplied to Dey by Meridian Medical Technologies and a worldwide license to the EpiPen trademark from Mylan. On October 1, 2009, Dey launched a new design of the epinephrine auto-injector in the United States, which provides enhanced features to the pen. Perforomist Solution is a formoterol fumarate inhalation solution offered by Dey. Perforomist Solution is a long-acting, beta2-adrenergic agonist indicated for long-term, twice-daily administration in the maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease patients, including those with chronic bronchitis and emphysema. Dey markets its products to a number of different customer audiences in the United States, including healthcare practitioners, wholesalers, pharmacists and pharmacy chains, home healthcare and long-term care.
Founded as Milan Pharmaceuticals Inc. by Milan Mike Puskar and Don Panoz in White Sulphur Springs, W.Va., as a pharmaceutical distribution company
Engaged in the development, manufacture and marketing of generic pharmaceuticals
AB MEDICAL PRS B.V.
DELOITTE & TOUCHE LLP
US SIC Code
1500, Corporate Drive
City province or state postal code
15317, CANONSBURG, PA
Phone: +1 724 514 1800
Fax: +1 724 514 1870
Country address: UNITED STATES OF AMERICA
Website url: www.mylan.com