After being raided by Federal officials, Ranbaxy Laboratories Ltd, India's largest pharmaceutical company, has been taken to court in the US by a consumer health group that supports the sale of low-priced generic medicines.
Boston-based Prescription Action Litigation Project, a coalition of more than 125 civil organisations working to bring down the prices of prescription drugs through class action litigation and public education, has filed a suit against Ranbaxy and three other generic companies -- Mylan, Teva and Barr -- as well as Cephalon Inc for allegedly delaying the US launch of Modafinil, the generic version of Cephalon's sleep disorder drug Provigil.
When contacted, Ranbaxy sources confirmed the development. However, a company spokesperson said an official comment would be provided only a day later.
Indian companies like Ranbaxy have been fighting a long and expensive battle with multinational pharmaceutical companies to enter the generics market in the West. In this, they have received support from groups that work for bringing down the cost of drugs. The PAL suit thus gives a new twist to the drama.
The suit, pending with the District Court of Pennsylvania, alleges that Cephalon paid $136 million to Ranbaxy, Mylan, Teva and Barr to postpone marketing Modafinil until 2011 or 2012, thereby blocking the availability of a cheap generic medicine.
The USFDA had tentatively approved Ranbaxy's abbreviated new drug application for Modafinil 100 mg and 200 mg tablets in August 2004. Cephalon, after initiating legal proceedings against the generic companies that had got the USFDA's nod, chose to settle the patent litigation out of court in December 2005.
According to the deal, Cephalon gave Ranbaxy a non-exclusive royalty-bearing right to market and sell its generic version from October 2011.
