Pfizer has settled another patent infringement lawsuit concerning its cholesterol-lowerer Lipitor, this time with Dr Reddy’s Laboratories.
The US giant had sued Dr Reddy’s in December 2009 to block generics of Lipitor (atorvastatin) before its various process and crystalline form patents expire in 2016 and 2017. However, the firms have now settled and a Delaware, has dismissed the case – the agreement is subject to review by the US Justice Department and the Federal Trade Commission, and financial terms have not been disclosed.
The settlement with Dr Reddy’s comes after similar agreements were reached with Teva Pharmaceutical Industries and Mylan, as well as Ranbaxy Laboratories. The Indian generics maker was the first company to seek regulatory approval for its version of Lipitor and plans to enter the market at the end of November when the enantiomer patent expires in the USA.
Ranbaxy has a 180-day period of exclusivity from the November date to sell its generic but the plan to launch may be delayed due to an ongoing US Food and Drug Administration investigation into quality standards at two Ranbaxy facilities.
Watson Pharmaceuticals has a separate deal with Pfizer to launch an authorised Lipitor generic beginning November 30.
