FDA granted Bristol-Myers Squibb and Sanofi-Aventis a boon: The companies nailed down pediatric exclusivity for their megablockbuster blood thinner Plavix. That means six extra months of sales unhindered by generic competition. Plavix's FDA exclusivity is now set to end on May 17, 2012, while patent protection expires later this year.
For Plavix, that's big money. According to BMS figures, the clotbuster delivered $6.1 billion in U.S. sales in 2009, and by the end of 2010's third quarter had brought in $4.95 billion.
Although not unexpected, the extension of U.S. exclusivity is especially important because Plavix already has generic competition in Europe. Copycats have been eating away at the drug's sales there; for the third quarter of 2010, Sanofi reported a 30 percent year-over-year sales drop to €505 million ($692 million). The French drugmaker reported €1.58 billion worth of Plavix sales during the first nine months of last year, or $2.1 billion (BMS markets the drug in the U.S., and the two companies share profits).
BMS and Sanofi well know how quickly Plavix's U.S. sales would erode when cheaper copies hit the market. Generics maker Apotex launched a version of the drug back in 2006, betting that it would prevail in an ongoing patent fight. The Plavix copycats flooded the market, and sales of the branded version dropped by more than 50 percent. A U.S. judge stopped the generic onslaught; BMS and Sanofi finally won $441 million in damages last year.