Dr Reddy’s and Fresenius Kabi get US FDA approval for generic Femara

The US Food and Drug Administration gave approval to Dr Reddy’s Laboratories and Fresenius Kabi Oncology, both listed Indian pharmaceutical companies, to market cancer drug letrozole or the generic version of Femara in the US. Novartis owns the patent for Femara, a drug used to treat breast cancer in post-menopausal women, which earned US-market sales of $682 million or Rs 3,100 crore in 2010.

Mylan Inc had the first to file status on the drug and started marketing it in the US from 25 April 2011. During the marketing exclusivity period, a 6-month window, no other generic can enter the market. The FDA approvals are a precursor to the drug going off patent, which will see all pharmaceutical companies with generic approval entering the market.

There are a total of 12 generic companies with approval to market this drug, of which four are Indian, and the remaining two are Natco Pharma and Sun Pharmaceutical Industries. The number of players will ensure that there is cut-throat competition for a share of the market, leading to price erosion.

The Rs 3,100 crore pie will thus shrink considerably and then get divided among the generic players and the innovator company. More approvals could also be in the pipeline, as the FDA clears pending applications prior to patent expiry. The patent is expected to expire some time in 2011.

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