Lupin gets USFDA nod for generic oral contraceptive drug

Company has received final approval, shall commence marketing the product shortly

Drug major Lupin today said it has received US health regulator's approval to market a generic version of Warner Chilcott Company, LLC's 'Ovcon 35' tablets, an oral contraceptive, in the American market.

The company has received final approval for its VyfemlaTM Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg) from the United States Food and Drugs Administration (USFDA), Lupin Ltd said in a statement.

"Lupin's US subsidiary Lupin Pharmaceuticals Inc (LPI) shall commence marketing the product shortly," it added.

The Mumbai-based company's product is indicated for the prevention of pregnancy in women who elect to use the product as a method of contraception.

According to IMS MAT March sales data, Warner Chilcott Company's Ovcon 35 tablets had annual US sales of around $22.3 million.

The oral contraceptive (OC) market in the US is valued at around $5 billion and is growing at around 8% annually.

Lupin entered the OC space in the US market in September 2011 and currently has one of the largest OC pipeline for the US market, with 34 filings and 14 approvals so far.

Lupin scrip today closed at Rs 853.40 on the BSE, down 0.34% from its previous close.