Pharma major Lupin‘s U.S. subsidiary- Lupin Pharmaceuticals, Inc. has received final approval for its Metformin Hydrochloride extended release tablets (HCL ER) 500 mg and 1000 mg from the United States Food and Drugs Administration (FDA). According to IMS health data, the total sales of Glumetza HCL ER tablets, 500 mg and 1000 mg in US, for the twelve months ending March, 2013, was approximately $144 million.
Lupin's Metformin HCL ER Tablets, 500 mg and 1000 mg strengths are the AB-rated' generic equivalent of Santarus, inc’s Glumetz HCL ER Tablets, 500 mg and 1000 me strengths. 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.
Metformin HCL ER tablets are biguanide and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Lupin 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.
