Sanofi fights to block generic Plavix in Germany
pharmafile | June 3, 2008 | News story | Sales and Marketing |Â Â Â
Sanofi-Aventis is taking legal action to prevent the launch of a generic competitor to its blockbuster Plavix in Germany.
At stake are sales worth £300 million and the company has promised to vigorously defend its European patent, which is not due to expire until 2013.
Swiss generics firm Schweizerhall has started registering its clopidogrel besylate with German federal regulator BfArM for approval, but not yet set a date for its launch.
Sanofi said in a statement that Schweizerhall's registrations refer to a different salt of clopidogrel to the one used in Plavix (clopidogrel bisulfate) and are for fewer indications.
"Sanofi-Aventis is convinced that these registrations have been obtained in violation of applicable laws and it has already filed legal action," the company said.
Schweizerhall intends to market its drug in a number of other European countries and said registration of the drug was a major milestone for the company.
Luzi von Bidder, chairman of Schweizerhall, said: "Clopidogrel will be the first more cost-effective alternative of this drug in the German market."
The Basel-based firm said applications for approval in other European countries are already in preparation, and could begin with Luxemburg as early as summer 2008.
Two years ago Sanofi and its marketing partner Bristol-Myers Squibb were caught out by a different generic version of Plavix in the US. Canadian firm Apotex flooded the market with its drug and seized a huge swathe of sales, before being ordered to stop.
Plavix works by thinning the blood to stop clots forming, and is used to prevent or treat cerebrovascular disease, coronary artery disease and peripheral vascular disease.
In Germany two branded versions of the drug are marketed. Sanofi sells it as Plavix and Bristol-Myers Squibb sells its as Iscover under the companies' long-standing alliance.
The pharma companies recently suffered another blow when they withdrew their European marketing submission for DuoPlavin – a new combination of Plavix and aspirin.
It was designed for patients already taking the two drugs to prevent atherothrombotic events in acute coronary syndrome. The companies withdrew the drug from review in order to conduct a bioequivalence study inline with data requests from European regulators.
