Basle, Switzerland - A generic version of clopidogrel is expected to be available soon in Germany, according to an announcement from Swiss pharmaceutical company Schweizerhall.

The company says that its generic subsidiary, Cimex, has successfully completed the decentralized approval procedure in Germany for its generic version of clopidogrel. "We expect shortly a positive ruling from the German authorization agency for medicines, and we plan to launch clopidogrel throughout the European Union in cooperation with marketing partners. A first license agreement with a major generics company was already concluded, and the signing of a contract with another generics provider is imminent. We expect first sales already in the current quarter," said Luzi A von Bidder, chair of Schweizerhall, in a press release [1].

Schweizerhall adds that clopidogrel could also obtain approval in Luxembourg within the second quarter of 2008. Applications for approval in additional European countries are in preparation. The European market for clopidogrel is currently about CHF 3.2 billion (€2 billion, $3.09 billion), of which Germany accounts for CHF 600 million, it says.

The Novartis subsidiary Sandoz and the generics company Ratiopharm have both said that they will be marketing the generic version of clopidogrel when it becomes available in Germany.

Clopidogrel is currently sold by Sanofi-Aventis and Bristol-Myers Squibb as Plavix or Iscover. Sanofi-Aventis said the drug is protected by patents until 2013 in Europe and 2011 in the US.

But von Bidder told heartwire that Schweizerhall is not infringing Sanofi's patent. "We are not patent infringing, but I have no further comments on this matter," he said. Analysts are suggesting that Schweizerhall has formulated a slightly different chemical version of the drug to get around the patent.

Von Bidder told heartwire that Schweizerhall was not going for the US market at this time. "We are just interested in the European market for the time being. The patent in Europe is slightly different from that in the US," he commented.

Plavix had worldwide sales last year of $7.3 billion, making it the world's second-largest-selling drug. Sanofi-Aventis said in a statement that it would "vigorously defend its intellectual property rights" in Europe. Sanofi and Bristol-Myers Squibb MS won a patent battle on clopidogrel in the US in 2007, after Apotex started selling a generic version of the drug. A US court ruled that Apotex had to stop selling its drug until the US patent on Plavix expired in 2011.