Jul 27 2007
Ranbaxy Laboratories Limited (RLL) has announced that the Company has reached an agreement with GlaxoSmithKline (GSK) resulting in a dismissal of their U.S. litigation with regard to Valtrex (Valacyclovir Hydrochloride tablets).
The lawsuit in the U.S. was related to GSK's U.S. Patent No. 4,957,924, covering Valacyclovir Hydrochloride which is used in the treatment of herpes virus infection. selHead
Under the agreement, Ranbaxy will enter the U.S. market in late 2009, whereby as the first generic company to file, it will enjoy a 180 days sales exclusivity. Ranbaxy has also obtained a license to GSK's U.S. 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 Bn (source IMS - MAT: Dec. 2006). selHead
In early February 2007, Ranbaxy received a final approval from the U.S. FDA to market and manufacture Valacyclovir Hydrochloride tablets. selHead
Ranbaxy will continue to pursue a strategy to effectively leverage and monetize it's pipeline of First-to-File (FTF) opportunities. The Company believes that it has a FTF status on approximately 20 Para IV ANDA filings, representing a market size of $26 Bn valued at innovator prices. selHead