US approves generic version of Sanofi's Plavix

The FDA announced Thursday that it approved generic versions of Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel) by multiple companies. Mylan, which holds 180 days of exclusivity to sell the 300-milligram dose, indicated that it has already begun making shipments of the drug in both the 300-milligram and 75-milligram doses.

Keith Webber, deputy director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said "for people who must manage chronic health conditions, having effective and affordable treatment options is important...The generic products approved today will expand those options for patients." In addition to Mylan, companies that have garnered FDA approval to market generic versions of the drug in the US include Dr. Reddy's Laboratories, Gate Pharmaceuticals, Teva, Apotex, Aurobindo Pharma, Roxane Laboratories, Sun Pharma and Torrent Pharmaceuticals.

As of Thursday, Bristol-Myers Squibb and Sanofi have launched the Plavix Choice programme, which offers discounts to patients who want to continue using branded Plavix. Bristol-Myers Squibb said it is not widely promoting the programme, but has reached out to current Plavix users to let them know it is available.
Plavix generated $6.7 billion in US sales in the year ended March 31.



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