Company Overview of Mylan Laboratories Limited
Mylan Laboratories Limited engages in the manufacture and supply of active pharmaceutical ingredients (APIs) in India and internationally. It offers its products in various therapeutic categories, including anti-bacterials, central nervous system (CNS) agents, antihistamine/anti-asthmatics, cardiovascular, anti-virals, anti-diabetics, anti-fungals, proton pump inhibitors, and pain management drugs. The company also maintains a portfolio of finished dosage forms of generic antiretroviral products used for the treatment of HIV/AIDS, including pediatric therapies. In addition, Mylan Laboratories offers contract research and development services during early stages of development and contract ma...
Plot No. 564/A/22
Road No. 92
Founded in 2001
Key Executives for Mylan Laboratories Limited
Head of Finanace and Senior Vice President
Compensation as of Fiscal Year 2013.
Mylan Laboratories Limited Key Developments
Ahold Files Lawsuit Against Medicis and Other Generic Companies over Alleged Anti-Trust Activities Associated with Acne Treatment Solodyn
Sep 10 13
Ahold USA has filed a lawsuit against Medicis Pharmaceutical and other generic drug manufacturers, including Impax Laboratories, Lupin Pharmaceuticals, Ranbaxy Pharmaceuticals, Sandoz, Mylan, Matrix Laboratories, Teva and Barr Laboratories in the US district court of Massachusetts. The lawsuit claims that the defendants had allegedly participated in anti-trust activities which limited access to generic versions of Medicis's acne treatment Solodyn (minocycline hydrochloride) in the United States. As a result, Ahold claims to have overpaid for the treatment as otherwise would have been the case, according to federal court documents filed on 9 September 2013.
Mylan Laboratories Limited Launches Generic Version of Revatio(R) Tablets
Nov 13 12
Mylan Inc. announced that its subsidiary Mylan Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. This product is the generic version of Pfizer's Revatio(R), which is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening. Revatio Tablets, 20 mg, had U.S. sales of approximately $338.7 million for the 12 months ending September 30, 2012, according to IMS Health. Mylan has begun shipping this product. Currently, Mylan has 172 ANDAs pending FDA approval representing $79.5 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
Teva Pharmaceutical Industries Ltd. Announces Court Ruling in Copaxone Patent Infringement Lawsuit Against Momenta Pharmaceuticals Inc, Sandoz, Mylan Laboratories Limited and Natco Pharma Limited
Jun 23 12
Teva Pharmaceutical Industries Ltd. announced that U.S. District Court for Southern District of New York has found in favor of Teva in the company's patent infringement lawsuit against Momenta Pharmaceuticals Inc./Sandoz and Mylan Laboratories Limited/Natco Pharma Limited regarding Teva's relapsing-remitting multiple sclerosis or RRMS product, COPAXONE. Accordingly, Teva filed lawsuit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of COPAXONE, methods of using the product and processes for manufacturing the product. The decision covers several patents, the last of which expires on September 1, 2015. The company noted that judge rejected Momenta/Sandoz and Mylan/Natco's claims that the COPAXONE patents are not valid and unenforceable and hence found that the purported generic versions of COPAXONE for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration or FDA approval infringe those patents. The ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE in the U.S. Teva stated that it also believes that the defendants would be enjoined from selling their products until the process patent expires on September 1, 2015. In addition, any purported generic version of COPAXONE would need to receive FDA approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of a purported generic synthetic peptide.
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