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Lupin Announces Settlement with SANTARUS and DEPOMED for GLUMETZA Patent Litigation

23-Feb-2012 | Source : | Visits : 9968
MUMBAI / BALTIMORE - Pharma major, Lupin Ltd. and its subsidiary, Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) announced in a press release, that it has entered into a settlement agreement with Santarus Inc. and Depomed, Inc. to resolve pending patent litigation involving GLUMETZA® (extended release metformin tablets) 1000 mg and 500 mg. 

The settlement agreement grants Lupin the right to begin selling a generic version of GLUMETZA on February 1, 2016, or earlier under certain circumstances. GLUMETZA® extended release metformin tablets, 1000 mg and 500 mg had annual US sales of approximately US$ 71 million, for the twelve months ending December, 2011 (IMS Health data). The settlement agreement is subject to review by the US Department of Justice and the Federal Trade Commission, as well as entry by the US District Court for the Northern District of California of an order dismissing the litigation. 

Lupin had earlier received the tentative approval for generic GLUMETZA® (Metformin Hydrochloride Extended Release Tablets) 1000 mg and 500 mg from the United States Food and Drugs Administration (FDA) in January, 2012. Lupin believes it is the first applicant to file an ANDA for GLUMETZA® 1000 mg & 500 mg strengths and as such is entitled to 180 days of marketing exclusivity.

Headquartered in Mumbai, India, Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs.

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