Lupin launches generic seasonale tablets

Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) 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 (FDA) 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. 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 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 U.S sales of approximately USD 81.2 million (IMS MAT Jun 2012 sales).