US FDA grants pediatric exclusivity for Sanofi/B-MS Plavix; rejects Gilead's filing for combination AIDS pill

In some good news for French drug major Sanofi-Aventis (Euronext: SAN) and US partner Bristol-Myers Squibb (NYSE: BMY), the companies revealed in a joint statement that the US Food and Drug has granted an additional six-month period of exclusivity to market their blockbuster blood thinner Plavix (clopidogrel). In the USA, the Plavix patent is now scheduled to expire on May 17, 2012, that than in November this year.

Both companies are facing patent losses on some of their leading drugs over the next few years, and Plavix has already been plagued with generic competition in Europe, even though the patent is not due to expire until February 2013, as well as in the USA, where in 2006 Canada-based Apotex launched a copy version of the drug on an “at risk” basis. Apotex was forced to withdraw its product. After a multi-year court battle to overturn the drug’s patent (The Pharma Letters passim)

Plavix generated US sales of $5.6 billion in the USA, with global turnover that year at $9.1 billion, according to data from IMS Health.