From the Wires
Mylan Confirms First-to-File Patent Challenge Relating to AMRIX(R)
- Mylan believes it has 180 days of sole marketing exclusivity -
By: PR Newswire
Dec. 1, 2008 08:01 AM
Mylan believes it is the first company to have filed a substantially
complete ANDA containing a Paragraph IV certification for the product and
expects to be awarded 180 days of sole marketing exclusivity once final
approval is obtained. Mylan filed its ANDA with the U.S. Food and Drug
Administration (FDA) in August. Cephalon, Eurand and Anesta filed a lawsuit
Cyclobenzaprine HCl ER Capsules, a muscle relaxant introduced to the
Currently, Mylan has 113 ANDAs pending FDA approval, 24 of which are potential first-to-file opportunities.
Mylan Inc., which provides products to customers in more than 140 countries and territories, 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 third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to the expected 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.
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