Pharma major Lupin and its subsidiary, Lupin Pharmaceuticals, Inc have 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 from February 1, 2016, or earlier under certain circumstances. GLUMETZA extended release metformin tablets, 1000 mg and 500 mg had annual US sales of approximately $71 million, for the twelve months ending December, 2011.
However, 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.
The company 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. The company believes that it is the first applicant to file an ANDA for GLUMETZA 1000 mg and 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. The company today has significant presence in the Cardiovascular, Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAID space in addition to holding global leadership positions in the Anti-TB and Cephalosporin segment.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1818.60 |
| Dr. Reddys Lab | 1336.00 |
| Cipla | 1475.05 |
| Lupin | 2159.00 |
| Zydus Lifesciences | 973.15 |
| View more.. | |
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