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New-York-based drugs giant Pfizer’s determination to defend its patents on the blockbuster cholesterol-lowerer atorvastatin (Lipitor®) has been rewarded again with the news that a court in Denmark has blocked the sale of a generic version of the drug.
Pfizer said the court has granted a preliminary injunction against Nomeco A/S, the largest pharmaceutical wholesaler in Denmark, that prohibits the sale of a generic version of atorvastatin made by Ranbaxy Laboratories. The Indian drugmaker launched its generic form of atorvastatin in Denmark, the first Western country to allow it, earlier in February.
The injunction, which is subject to possible appeal by Nomeco, requires Ranbaxy’s product to be withdrawn from the Danish market pending the outcome of a patent infringement trial in Denmark that has not yet been scheduled. At issue are three Pfizer patents covering processes and intermediate compounds. Pfizer says it has coverage for atorvastatin until November 2011.
Nomeco said it had been selling generic atorvastatin for about a week but did not disclose how much product needed to be recalled. Ranbaxy, which could be subject to financial penalties for lost sales of the drug suffered by Pfizer, has yet to comment on the injunction.
Meanwhile, Ranbaxy suffered another reverse when a court in the United States backed Japan’s Astellas Pharma and Germany’s Boehringer Ingelheim in a lawsuit which will stop the Indian firm launching a generic version of tamsulosin (Harnal®, Flomax®) for benign prostatic hyperplasia.
Astellas and Boehringer, which jointly market the drug in the US, filed a patent infringement lawsuit in the US against Ranbaxy in May 2005, after the latter submitted an abbreviated new drug application for generic tamsulosin. With this latest ruling, Ranbaxy’s ANDA® will not be approved before the US patent on Flomax expires in October 2009.