Pharma major, Lupin’s subsidiary - Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its Levonorgestrel and Ethinyl Estradiol tablets USP, 0.1 mg / 0.02 mg from the United States Food and Drugs Administration (USFDA) to market a generic version of Watson Laboratories, Inc.’s Lutera 28 tablets. As per IMS MAT Sept 2012 sales, Lutera tablets had annual US sales of approximately $103.6 million.
Lupin’s Levonorgestrel and Ethinyl Estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its generic product shortly.
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
