Upholding the 180-day exclusivity of Ranbaxy Laboratories on Simvastatin, the US Court of Appeals has affirmed a similar verdict given by a district circuit earlier. The drug went off patent in the US on June 23 this year, following which Ranbaxy had begun to market the drug in the exclusivity period. It has a 60 per cent market share in the 80 mg simvastatin market, stated a Ranabxy release.Merck, the patent holder of the $6 billion cholesterol-lowering drug, had delisted the patent from the Orange Book over a year ago. It had raised doubts over the legality of granting six months exclusivity to patent challengers such as Ranbaxy. Even though the decision does not change anything for the drugmakers for now, the verdict has shot down delisting of patent as a method of obstructing patent challenges from generic players.
