Pharma major, Lupin’s subsidiary, Lupin Pharmaceuticals Inc, has received final approval for its Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg from the United States Food and Drugs Administration (USFDA) to market a generic version of Teva Branded Pharmaceuticals (Teva) Seasonale Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.
Lupin's Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg are the AB-rated generic equivalent of Teva’s Seasonale Tablets. Lupln’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.
Besides, Lupin is marketing its Levonorgestrel and Ethinyl Estradiol tablets in 84 pink active tablets each containing 0.15 mg of Levonorgestrel, a synthetic progestogen and 0.03 mg of Ethinyl Estradiol, and 7 white inert tablets. Seasonale tablets had annual US sales of approximately $81.2 million (IMS MAT Jun 2012 sales).
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).
