US FDA approves generic versions of blood thinner Plavix

18 May 2012

Coinciding with the loss of patent protection on Sanofi (Euronext: SAN) and Bristol-Myers Squibb’s (NYSE: BMY) blockbuster blood thinner yesterday, the US Food and Drug Administration announced that it has approved several generic versions of Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

Dr Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceutical Industries have gained FDA approval for 300mg clopidogrel. Apotex Corp, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva, and Torrent Pharmaceuticals have received approval for 75mg clopidogrel.

180 days exclusivity for Mylan and Dr Reddy’s

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