Sanofi, BMS’ Plavix Wins Six Months of Protection From Generics
February 8, 2011
The FDA has granted Sanofi-Aventis and Bristol-Myers Squibb (BMS) six months of pediatric exclusivity on their blockbuster blood-thinner Plavix. With the additional patent protection, Sanofi and BMS will now be able to protect Plavix (clopidogrel bisulfate) from generic competition until at least May 17, 2012, the companies said. Plavix is among the world’s best-selling drugs, and Sanofi and BMS have faced extensive efforts from generic-drug makers to invalidate the drug’s patents. Apotex went as far as to proceed with an at-risk launch of its generic Plavix in 2006, but the drug’s patent protection was upheld by a federal court in New York.