Ranbaxy Laboratories 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 infections.
Under the agreement, the company will enter the US market in late 2009 whereby as the first generic, the company will enjoy a 180 days exclusivity. In early February 2007, the company received a final approval from the US FDA to market and manufacture Valacyclovir Hydrochloride tablets.
Company 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 – US $ 26 billion valued at innovator prices.