FDAnews Drug Daily Bulletin

Swiss generics maker Cimex, a division of Schweizerhall Group, has received final approval from Germany’s Federal Institute for Drugs and Medical Devices for the anti-platelet drug clopidogrel, which will compete with Bristol-Myers Squibb (BMS) and sanofi-aventis’ blockbuster Plavix.

Clopidogrel is a major moneymaker for sanofi and BMS, which market it as Plavix (clopidogrel bisulfate) in the U.S. and Iscover elsewhere. For the first quarter of the year, sanofi-aventis reported the drug’s net sales at $1.02 billion, an 18.9 percent increase from last year. European sales were $680 million, and U.S. sales were $76 million. BMS reported a sales increase of 39 percent to $1.31 billion, including $1.14 billion in the U.S., for the same period.

Schweizerhall estimates the current annual European market for clopidogrel to be $3.07 billion of which Germany accounts for $575 million.

Luzi von Bidder, Schweizerhall’s chairman, said the approval marks the first time a cost-effective alternative to Plavix will come on the German market.

Sanofi said it is aware of the German approval of third-party clopidogrel applications. It emphasized that the products contain besylate, a different salt than that used in Plavix. The company added it was convinced the approval was obtained in violation of applicable laws and has filed legal action.