British drugmaker AstraZeneca Plc today agreed to settle a patent infringement lawsuit against generic drug manufacturers Egis Pharmaceuticals and Watson Laboratories, a unit of Actavis Inc. over its best-selling drug Crestor.
The settlement comes after a US court upheld AstraZeneca's patent on Crestor, a cholesterol-lowering drug that has annual sales of $6.25 billion.
AstraZeneca had filed a suit against Watson and Egis in the US District Court for the District of Delaware, alleging that Watson's rosuvastatin zinc NDA infringed AstraZeneca's substance patent covering Crestor.
Watson (formerly known as Watson Pharmaceuticals, Inc.) and Egis filed counterclaims seeking declaratory judgment of non-infringement and invalidity of the substance patent.
In December 2012, the London-based drugmaker won a ruling from the court that blocked generic versions of the drug in the US until July 2016.
Under the deal, AstraZeneca will allow Actavis and Egis Pharmaceuticals to start selling the generic version of Crestor from 2 May 2016. Actavis will pay AstraZeneca 39 per cent of net sales until the end of pediatric exclusivity on 8 July 2016.
AstraZeneca said that all claims and counterclaims will be dismissed and the agreement with Watson and Egis would now be filed with the US Federal Trade Commission and the US Department of Justice.
''This agreement ensures that consumers will benefit from an earlier launch of a rosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavis had proceeded to launch the alternate product,'' Paul Bisaro, president and chief executive officer of Actavis, said in a statement.