GSK to block Ranbaxy's Augmentin launch

Leading domestic drug company Ranbaxy's plan to launch the generic version of GlaxoSmithKline's Augmentin in the US in April 2007 has been challenged by the latter.

The multinational drug major will approach US courts for a preliminary injunction prohibiting the launch of this product until the completion of the lawsuit, a Reuters report said.

In a statement issued on February 2, GSK had said under the terms of an agreement with Ranbaxy (previously approved by the US District Court of New Jersey), if it applies for an injunction within 45 days, Ranbaxy will not be able to launch its product until the court decides on the matter.

In May 2003, GSK had filed a patent infringement suit against Ranbaxy, alleging that its generic product would infringe on the basic "composition of matter" patent for Valtrex, which expires in June 2009 (excluding paediatric exclusivity). Ranbaxy, which got US regulatory approval to market the product on February 1, 2007, had announced its plans on the same day.

Commenting on the US Food and Drug Administration approval to market certain strengths of generic Amoxicillin and Clavulanate Potassium, Jim Meehan, vice-president of sales and marketing for Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy, had on February 1 said with the approval, the company was "adding yet another product that has clinical utility and value, and as such, will distinguish Ranbaxy in the years to come. The product will be available in April 2007".

However, when contacted, a Ranbaxy spokesperson refused to comment on GSK applying for an injunction.