Drug firm Lupin today said it has received US health regulator’s approval to market Drospirenone and Ethinyl Estradiol tablets, an oral contraceptive drug, in the American market.
The company’s subsidiary, Lupin Pharmaceuticals Inc has received final approval from the US Food and Drug Administration (USFDA) for its Drospirenone and Ethinyl Estradiol tablets in strength of 3 mg/0.03 mg, Lupin said in a statement.
The Mumbai-headquartered firm’s product is the generic equivalent of Bayer’s Yasmin tablets and is an oral contraceptive indicated for the prevention of pregnancy in women, it added.
“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,” the company said.
According to IMS MAT Sept 2012 sales data, Yasmin tablets had annual US sales of nearly $275.1 million.
The current approval is the seventh for Lupin in the oral contraceptive space (OC). The company’s current abbreviated new drug application (ANDA) filings for OC’s stand at 30, the company said.
The oral contraceptive market in the US is valued at around $5 billion and growing at around 8-10 per cent annually and is dominated by few companies like Teva, Watson, Sandoz and Bayer.
Shares of Lupin were trading at Rs 618.45 on the BSE in late afternoon trade, up 1.62 per cent from its previous close.