Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Metformin Hydrochloride Extended Release Tablets (HCl ER) 500 mg and 1000 mg from the United States Food and Drugs Administration (USFDA).
Lupin’s Metformin HCl ER Tablets, 500 mg and 1000 mg strengths are the AB-rated generic equivalent of Santarus, Inc.’s Glumetza HCl ER Tablets, 500 mg and 1000 mg strengths. Metformin HCl ER tablets is a biguanide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
As per IMS Health data, Glumetza HCl ER tablets, 500 mg and 1000 mg had annual US sales of approximately $58 million, for the twelve months ending Sep, 2011. The company believes that it is the first applicant to file an ANDA for Glumetza HCL ER Tablets, 500 mg & 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity.
Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.
