Healthcare Industry News: metformin
News Release - November 30, 2009
Depomed Files Patent Infringement Lawsuit Against Lupin LimitedMENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (Nasdaq:DEPO ) today announced that it has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA® (metformin hydrochloride extended release tablets).
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Lupin with the U.S. Food and Drug Administration (FDA) regarding Lupin’s intent to market generic versions of 500mg and 1000mg strengths of GLUMETZA prior to the expiration of the four listed patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340).
Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Lupin’s ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
“We have full confidence in the intellectual property rights protecting our GLUMETZA products. We intend to vigorously defend and enforce our intellectual property rights, as we have in previous infringement actions,” commented Matthew M. Gosling, Depomed’s vice president and general counsel.
Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Solvay Pharmaceuticals. A New Drug Applications for DM-1796 is expected to be filed with the FDA in the first quarter of 2010. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, www.depomed.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our patent litigation against Lupin Limited; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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