Sanofi fined by France over Plavix’s generics claims

May 14, 2013 | By Márcio Barra


Sanofi, the French drug multinational, was fined yesterday by the French Competition Authority,   following a complaint filed by Teva Sante (a French unit of Israel-based Teva Pharmaceutical Industries) back in 2010. The fine was due to Sanofi’s communication practices towards health professionals, which discouraged the use of generic versions of Plavix.

Plavix (Clopidogrel bisulfate), an  antiplatelet agent launched in 1997 used to inhibit blood clotting in a series of heart conditions, was one of the world’s bestselling drugs, only behind Lipitor in 2011. Its patent ended in May 2012 in the U.S.and will end in 2013 in Europe. In the May last year, EMA’s CHMP approved six Plavix generics, four of them from the Swiss company Acino, one by Teva, and another by Pharmathen. These generics were able to be launched by sidestepping the technicalities of Plavix’s European patent, as generic makers mixed the active ingredient clopidogrel with a different salt, like besylate or hydrobromide, instead of bisulfate.

Sanofi’s communication to health professionals “created a doubt over the quality and the safety of generics, without any proven basis, as nothing could demonstrate that Plavix generics were less safe than (the original drug),” the French Competition Authority said in a statement.

Sanofi, in a released statement, is “currently reviewing all the points to prepare an appeal before the Paris appeals court,” since “Sanofi never challenged the bio-equivalence of Plavix generics,” and ” never specifically targeted the Teva Sante generic or other Plavix generic versions.”

For an overview of Sanofi’s first quarter 2013 earnings, please follow this link. 




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