Depomed has filed another lawsuit against Indian generic maker Lupin in the District Court of Maryland, USA alleging patent infringement on its anti-diabetic pill Glumetza.
Lupin’s abbreviated new drug application (ANDA) with US FDA seeking permission to market a generic version of extended release metformin hydrochloride (Glumetza) infringed Depomed’s four valid patents, the company said.
Glumetza’s US Patent No. 6,340,475 is set to expire in 2016, US Patent No. 6,488,962 will expire in 2020, US Patent No. 6,635,280 will expire in 2016 and US Patent No. 6,723,340 will expire in 2021.
Meanwhile, Lupin, in its certification notice, said that Depomed’s US Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for Glumetza are invalid and/or will not be infringed by Lupin’s commercial manufacture, use or sale of the products described in Lupin’s ANDA.
Lupin Ltd has issued a Paragraph IV certification notice to Depomed, Inc regarding filing of an ANDA with the US FDA for a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths.
Depomed sells Glumetza extended release tablets in 500 mg and 1000 mg strengths.
Glumetza (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States.Santarus, Inc promotes Glumetza in the United States.
In November Depomed filed suit in the Northern District Court of California asking to stop Lupin from launching Glumtza generic in US.
Depomed filed this action as a “protective measure to preserve its rights and interests, given the possible consequence if Defendants succeeded with such unjustified action, Plaintiff had no choice but to file this second action out of an abundance of caution,” the lawsuit said.
Depomed also expects that personal jurisdiction will be maintained in the Northern District of California and that the action will proceed in that forum, in which case this second action would be unnecessary.
Lupin has settled several patent infrigment lawsuit on earlier occasions including that of Effexor XR, desloratadine and ramipril with brand name companies after challenging them as a startegy in previous years.
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.
Depomed’s 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 Serada is in Phase 3 clinical development for menopausal hot flashes.
Depomed formulates its products and product candidates with its proprietary Acuform 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.