Sanofi plans to appeal German Plavix copies

French drug major Sanofi-Aventis says that a German administrative court has allowed two firms to continue marketing generic versions of its anticoagulant Plavix (clopidogrel), despite Sanofi claiming German marketing authorizations for the products were based on data that was exclusive until last month (Marketletter May 19).

The German court in Cologne overturned the previous suspension of marketing authorization for copy clopidogrel held by German firms YES Pharmaceutical Development Services GmbH and a subsidiary of the Ratiopharm Group. Sanofi maintains that the authorizations for the generics are based on data shared with Bristol-Myers Squibb that was protected up until July 15.

The French firm says it intends to appeal the decisions and that the marketing authorizations for the drug are still subject to a third-party objection procedure before the German Federal Institute for Drugs and Medical Devices (BfArM).