Ranbaxy Laboratories Ltd to enter US in 2009

New Delhi, July 26: Ranbaxy Laboratories Ltd (RLL) today said it has reached an agreement with GlaxoSmithKline (GSK) to dismiss their US litigation with regard to Valtrex(r) (Valacyclovir Hydrochloride tablets) and look to enter US markets in 2009.

The lawsuit in the US was related to GSK's US Patent, covering Valacyclovir Hydrochloride and its use in the treatment of herpes virus infection, said a statement.

Under the agreement, Ranbaxy will enter the US market in late 2009 and it will enjoy a 180 days exclusivity. Ranbaxy has also obtained a license to GSK's US Patent, listed in the Orange Book for Valacyclovir. The total annual market sales of Valtrex were around 1. 3 billion dollars.

In early February 2007, Ranbaxy had received a final approval from the US FDA to market and manufacture Valacyclovir Hydrochloride tablets.

''Ranbaxy will continue to pursue a strategy to effectively leverage and monetise it's pipeline of FTF opportunities. The company believes that it has a First-to File (FTF) status on 20 Para IV ANDA filings representing a market size of 26 billion dollars'', said Ranbaxy in the statement.

UNI