Lupin gets FDA nod for oral contraceptive

Tags: News
Mumbai-headquartered Lupin has received approval from food and drugs administration (USFDA) to sell generic version of Watson Laboratories’ Lutera tablets. Lutera is an oral contraceptive drug.

The move will help company strengthen its oral contraceptive product basket. It is Lupin’s seventh oral contraceptive product approved by the USFDA. US is the largest drug market in the world and accounts for about one-third of volumes for the company. Oral contraceptive is less competed for segment. There are just three players in the market for this product: Vintage, Teva and Watson. Lupin’s has filed 32 products in the oral contraceptive segment with the FDA and waiting for approval.

Lupin’s levonorgestrel and ethinyl estradiol tablets, having strength of 0.1 mg and 0.02 mg, are combined oral contraceptives prescribed for the prevention of pregnancy in women who choose to use oral contraceptives as a method of avoiding pregnancy.

“Lutera had annual US sales of approximately $103.6 million. Lupin will be marketing its generic product shortly,” said a company statement. The generic market for oral contraceptives is estimated at $1.2 billion.

Last month, Lupin received approval from USFDA for its oral contraceptive drug Yasmin that had annual sales of $275 million in the US.

In the quarter that ended September 30 Lupin reported consolidated revenue of Rs 2,301 crore with net profit of Rs 290 crore. The company is expected to declare its quarterly result on January 31.


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