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.