Lupin gets US nod for 7th oral contraceptive

MUMBAI: Drug maker Lupin received final US approval for its oral contraceptive Levonorgestrel and Ethinyl Estradiol, the seventh in the category, the Indian company said in a statement on Tuesday. The drug is a generic version of Watson Laboratories’ Lutera.

Lupin has 32 more products filed for approval with the US Food and Drug Administration department in the oral contraceptive segment. "We plan a full cross section of products in the segment," said the company spokesman Shamsher Gorawara.

This is Lupin’s first year of offerings in the segment, but it expects to clock over $100 million (Rs 538 crore) in the next financial year that begins in April, a company executive had said. Gorawara said the company does not give out segment wise revenue breakup.

The generic market for oral contraceptives is estimated at $1.2 billion (Rs 6,457 crore). Lutera had annual U.S sales of approximately $103.6 million (Rs 557 crore).

In the quarter that ended on September 30 Lupin reported consolidated revenue of Rs 2301 crore with net profit of Rs 290 crore.