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Ranbaxy and GSK agree to settle on US valacyclovir patent

Ranbaxy reaches an agreement with GSK to dismiss its US litigation with regard to anti-infective Valtrex

India-headquartered Ranbaxy has reached an agreement with GlaxoSmithKline (GSK) to dismiss its US litigation with regard to anti-infective, Valtrex (valacyclovir).

The US lawsuit was related to GSK's US Patent 4,957,924, covering valacyclovir and its use in the treatment of herpes simplex infection.

Per the agreement, Ranbaxy will enter the US market in late 2009 as the first generic version of valacyclovir and company will benefit from a 180-day exclusivity arrangement. Ranbaxy received a final approval from the FDA to market and manufacture valacyclovir tablets in February 2007.

Ranbaxy has also obtained a license to GSK's US Patents 5,879,706 and 6,107,302, listed in the Orange Book for valacyclovir. The total annual market sales of Valtrex were approximately USD 1.3bn, according to IMS MIDAS data.

Ranbaxy says it has a First-to File (FTF) status on around 20 Para IV ANDA filings, which at current ethical prices could offer a potential market size of USD 26bn.

30th July 2007

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