Ranbaxy, GSK to settle valacyclovir patent case in US
26 Jul 2007
Mumbai: Ranbaxy Laboratories Ltd has reached an agreement with GlaxoSmithKline (GSK) to call off a patent suit in the US 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, Ranbaxy will enter the US market in late 2009 whereby as the first generic, the company will enjoy a 180 days exclusivity. The company has also obtained a licence to GSK's US Patent Nos. 5,879,706 and 6,107,302, listed in the Orange Book for Valacyclovir. Valtrex had total annual market sales of around $1.3 billion.
Ranbaxy received the final approval from the US FDA to manufacture and market valacyclovir hydrochloride tablets as early as February this year.
The company will continue to pursue a strategy to effectively leverage and monetise it's pipeline of FTF opportunities.
Ranbaxy said it has a first-to-file (FTF) status on approximately 20 Para IV ANDA filings representing a market size of $26 billion, valued at innovator prices.
Meanwhile, GSK board of directors is meeting, inter alia, to consider and approve the unaudited financial results for the April-June quarter and the half-year ended June 30, 2007.
The board will also take up for consideration, a proposal for the proposed divestment of the company's fine chemicals business.
