Sanofi-Aventis and Bristol-Myers Squibb are facing generic threat on Plavix or Iscover (Clopidogrel) in Europe from Schweizerhall (Swiss company). Schweizerhall announced that its close to winning approval for a generic version of the blood-thinning product in Germany and Luxembourg. The company furter added that it will launch the generic version before the end of June.
Sandoz, Hexal and Ratiopharm will be the marketing partner of Schweizerhall.
The EP281459 claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. But Schweizerhall said it was close to launching a generic version despite this.The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form.
Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries.
The Basel-based company expects approval shortly from German regulators for its version of clopidogrel, as Plavix is known generically, and it plans to launch the drug throughout the European Union in cooperation with marketing partners.
The Ippharmadoc believes that Schweizerhall may have design around EP281459 by developing a different salt form of clopidogrel.
Plavix suffered a major decrease in sales after Apotex launched a generic form of the medicine in August 2006. Although a New York federal judge blocked the sale of the generic weeks later, the huge supplies already on the market undermined sales of Plavix through early 2007. Recently, BMS and Sanofi were succcessful in blocking generic version in USA as reported earlier by this blog.
Sandoz, Hexal and Ratiopharm will be the marketing partner of Schweizerhall.
The EP281459 claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. But Schweizerhall said it was close to launching a generic version despite this.The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form.
Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries.
The Basel-based company expects approval shortly from German regulators for its version of clopidogrel, as Plavix is known generically, and it plans to launch the drug throughout the European Union in cooperation with marketing partners.
The Ippharmadoc believes that Schweizerhall may have design around EP281459 by developing a different salt form of clopidogrel.
Plavix suffered a major decrease in sales after Apotex launched a generic form of the medicine in August 2006. Although a New York federal judge blocked the sale of the generic weeks later, the huge supplies already on the market undermined sales of Plavix through early 2007. Recently, BMS and Sanofi were succcessful in blocking generic version in USA as reported earlier by this blog.
