Depomed Files Patent Infringement Lawsuit Against Lupin

Depomed has filed a lawsuit in the US District Court for the Northern District of California against Lupin and its wholly-owned subsidiary, Lupin Pharmaceuticals, 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 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 6340475, 6488962, 6635280 and 6723340).

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.

Matthew Gosling, vice president and general counsel of Depomed, said: “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.”