The Acino Group has won favorable German court ruling in the legal proceedings regarding Clopidogrel Besylate. In a significant decision by the German High Court (Oberverwaltungsgericht) Nordrhein-Westfalen, dismissed the objections against the immediate enforcement of the drug approval for clopidogrel, developed by Acino. The initial drug approval therefore remains in effect and the generic clopidogrel Besylate by Ratiopharm and Hexal for 75 mg tablets, which were launched in July 2008, will remain in the market. The generic oproduct is 25% Cheap in comparison to innovator product Clopidogrel Bisulfate.
Also, Swiss generics maker Schweizerhall had earlier received German approval for clopidogrel Besylate (Sanofi's aproved form is Clopidogrel bisulfate in May. Sandoz (generic unit of Novartis) was set to market generic Plavix in Germany as per their agreement with Schweizerhall
Earlier, In a significant ruling favoring generic palyers in July, 2008 ,a German court has allowed generic launch of Clopidogrel besylate. the German Administrative Court in Cologne (Verwaltungsgericht Köln) had ordered the immediate execution of the product approval granted by the BfArM (Federal Institute for Drugs and Medical Devices, ). This ruling led Cimex AG, Schweizerhall and Novartis to launch this product in Germany and subsequently into the European market. Innovator Sanofi-Aventis and its U.S. partner Bristol-Myers Squibb announced that they would challenge a German court's decision to immediately authorize marketing of the generic versions of their blockbuster blood thinner Plavix (Clopidogrel). This was later challenged by innovator Sanofi-Aventis und Bristol-Myers Squibb. Afterwards, Sanofi-Aventis appealed to the German Higher Administrative Court Nordrhein-Westfalen against the ruling issued by the Administrative Courtin Cologne requesting a temporary suspension of the drug approval. However, the Higher Administrative Court Nordrhein-Westfalen dismissed this appeal on August 1, 2008. The latest decision of the Administrative Court Nordrhein-Westfalen regarding these preliminary legal proceedings can not be challenged by ordinary appeal.
Importantly, the above decision will increase chances of subsequent generic approval in other major European countries.
Clopidogrel was first disclosed in EP99802, which covers Clopidogrel racemic form generically. The said patent has expired in 2003 in most European countries. The innovator's patent EP281459, claims enatiomeric form of Clopidogrel sulfate as product and will expire on 15 Feb, 2013 (with SPC) in most European countries. The innovator has claimed various salts of Clopidogrel like hydrochloride, hrdrobromide, taurocholate and bisulfate form. generic companies designed around against the said patent by developing Besylate salt, not covered in the '459 patent.
Acino press release: Here
Earlier news of IPPharmadoc on this product Here
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