PITTSBURGH, June 4 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor(R) Tablets.
Mylan believes that Matrix is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for the product. Matrix filed an ANDA with the U.S. Food and Drug Administration (FDA) in early 2008.
Daiichi Sankyo filed a lawsuit yesterday in the U.S. District Court for the District of New Jersey alleging infringement of the sole patent relating to Azor, which is listed in the "Orange Book" as U.S. Patent No. 5,616,599.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
This press release includes statements that constitute "forward-looking statements," including with regard to first to file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
SOURCE Mylan Inc.