Ranbaxy and GSK settle over Valtrex

Indian generic drugs major Ranbaxy Laboratories says that it has reached a deal with UK pharmaceutical giant GlaxoSmithKline resulting in the dismissal of their US litigation over the antiviral Valtrex (valacyclovir HCl). The dispute concerned GSK's US patent no 4,957,924 covering the drug, which is used for the treatment of herpes virus infection.

Under the agreement, Ranbaxy will enter the US market in late 2009 whereby, as the first generic company to file for approval, it will enjoy 180 days of sales exclusivity. Ranbaxy has also obtained a license to GSK's US patent nos 5,879,706 and 6,107,302, listed in the Orange Book for valacyclovir. The total annual sales of Valtrex were around $1.3 billion in the 12 months to December 2006, according to IMS Health data. In early February, Ranbaxy received a final Food and Drug Administration approval to market and manufacture valacyclovir.