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MUMBAI, India, and BALTIMORE — Lupin Ltd. is set to market levonorgestrel and ethinyl estradiol tablets (0.1 mg/0.02 mg), an oral contraceptive, in the United States.
The India-based drug maker said Tuesday that its subsidiary Lupin Pharmaceuticals Inc. has received final approval for the product — a generic version of Watson Laboratories Inc.’s Lutera 28 tablets — from the Food and Drug Administration.
Lupin reported that it plans to release its generic product soon. Lutera tablets have annual U.S sales of about $103.6 million, according to IMS Health figures cited by Lupin.
Lupin added that it entered the U.S. birth control pill market with the launch of its generic for Nor-QD (norethindrone) in September 2011 and noted that the company has the largest oral contraceptive pipeline for the U.S. market, with 32 FDA filings and seven approvals thus far.
In December 2012, Lupin launched a generic version of Yasmin (drospirenone and ethinyl estradiol), which has annual sales of $275.1 million, based on IMS Health data.
