Ranbaxy & GSK to settle Valacyclovir US Patent Litigation

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Ranbaxy & GSK to settle Valacyclovir US Patent Litigation

Ranbaxy & GSK enter into an agreement to settle Valacyclovir US Patent Litigation. Ranbaxy to launch Valacyclovir Hydrochloride Tablets in late 2009 with 180 days exclusivity

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Ranbaxy Laboratories Limited (RLL) announced today that the Company has reached an agreement with GlaxoSmithKline (GSK) to stipulate a dismissal of their US litigation with regard to Valtrex® (Valacyclovir Hydrochloride tablets).  The lawsuit in the US was related to GSK's US Patent No. 4,957,924, covering Valacyclovir Hydrochloride and its use in the treatment of herpes virus infection.

Under the agreement, Ranbaxy will enter the US market in late 2009 whereby as the first generic, the Company will enjoy a 180 days 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 market sales of Valtrex were around USD 1. 3 Bn ( source IMS)

In early February 2007, Ranbaxy 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 monetize it's pipeline of FTF opportunities. The Company believes that it has a First-to File (FTF) status on approximately 20 Para IV ANDA filings representing a market size of  USD 26 Bn valued at innovator prices.  

Sourced From: Ranbaxy Laboratories Ltd