Ranbaxy drops Hatch-Waxman challenge to Novartis' Diovan

The HinduBusinessLine reports: Ranbaxy Laboratories has dropped its patent challenge of Novartis AG’s hypertension drug Diovan.

The Gurgaon-based company has changed its Para IV application with the US Food and Drug Administration, into a Para III application, committing not to sell its generic version of Diovan before its patent expires in September 2012 or is invalidated before the date. Generic makers file Para IV applications challenging the validity of the innovator’s patent.

Ranbaxy had filed a Para IV challenge against the patent covering ‘valsartan’, the active ingredient of the hypertension drug. Following which the Swiss company, filed a suit against Ranbaxy in August claiming infringement of its patent.

Novartis is reported to have asked a federal court in Newark, New Jersey, on Friday, Sept. 21, 2007, to drop the case.

Diovan is Novartis’ biggest seller; it notched up sales of $2.4 billion in the first half of the year accounting for 20 per cent of the company’s sales.