Lupin receives USFDA approval to launch generic Yasmin tablets

19 Dec 2012 Evaluate

Pharma major, Lupin’s subsidiary, Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its Drospirenone and Ethinyl Estradiol Tablets, 3 mg / 0.03 mg from the United States Food and Drugs Administration (USFDA) to market a generic version of Bayer Healthcare’s (Bayer) Yasmin Tablets 3 mg / 0.03 mg.  As per IMS MAT Sept 2012 sales, Yasmin Tablets had annual US sales of approximately $275.1 million.

Lupin’s Drospirenone and Ethinyl Estradiol Tablets are the AB rated generic equivalent of Bayer’s Yasmin Tablets 3 mg / 0.03 mg. Lupin’s Drospirenone 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 Drospirenone and Ethinyl Estradiol Tablets USP in a wallet pack of 28 tablets consisting of 21 yellow active tablets, each containing 3 mg Drospirenone and 0.03 mg Ethinyl Estradiol, and 7 white inert tablets. 

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).

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