Pharma major Lupin Limited announced that its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its metformin hydrochloride extended release tablets (HCl ER) 500 mg and 1000 rug from the United States Food and Drugs Administration (FDA).
Lupin's metformin HCl ER tablets, 500mg and 1000mg strengths are the AB-rated generic equivalent of Santarus Inc.'s Glumetza HCl ER tablets, 500mg and 1000mg strengths. Metformin HCl ER tablets is a biguanide and is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Glumetza HCl ER tablets, 500mg and 1000mg had annual US sales of approximately US$ 58 million, for the twelve months ending September, 2011 (IMS Health data). Lupin believes that it is the first applicant to file an ANDA for Glumetza HCl ER tablets, 500mg & 1000mg strengths and as such will be entitled to 180 days of marketing exclusivity.
Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. The company has significant presence in the cardiovascular, diabetology, asthama, paediatrics, CNS, GI, anti-infectives and NSAID space in addition to holding global leadership positions in the anti-TB and cephalosporin segments.