The Mumbai-based company has received final approval for its VyfemlaTM Tablets (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4mg/0.035 mg) from the US Food and Drugs Administration (USFDA).
"Lupin's US subsidiary Lupin Pharmaceuticals Inc (LPI) shall commence marketing the product shortly," Lupin said in a statement.
The oral contraceptive (OC) market in the US is valued at around USD 5 billion and is growing at around 8 percent annually.
According to IMS MAT March sales data, Warner Chilcott Company's Ovcon 35 tablets had annual US sales of around USD 22.3 million.
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.
--IANS (Posted on 27-09-2013)