US FDA approves Lupin's generic version of Teva's Seasonique and Taro's Topicort

Indian drugmaker Lupin (BSE: 500257) saw its shares gain 2.3% to 659.65 rupees by close of trading on Friday (April 12), when the company said that its US subsidiary has received final approval for its Daysee (levonorgestrel and ethinyl estradiol) tablets, from the US Food and Drugs Administration to market a generic version of Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) branded contraceptive drug Seasonique. Lupin has already commenced shipping the product, the company said.

Lupin's Daysee tablets are now available in the USA in extended-cycle wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15mg of levonorgestrel and 0.03mg of ethinyl estradiol, and 7 mustard tablets, each containing 0.01mg of ethinyl estradiol. The light blue tablets are round, biconvex, film-coated tablets, debossed with "LU" on one side and "V21" on the other side. The mustard tablets are round, biconvex, film-coated tablets debossed with "LU" on one side and "V22" on the other side.

The total US sales for branded and generic of the product stood at $161 million in the year ended December 2012, according to IMS Health data quoted by Lupin. The oral contraceptive market in the USA is valued at around $5 billion and is forecast to be growing at around 8% annually.