Ranbaxy and GSK Reach Settlement on Launch of Generic Valtrex

Indian generic drug manufacturer Ranbaxy announced last week that the company has settled its litigation with GlaxoSmithKline over generic Valtrex. Ranbaxy received final FDA approval for its generic drug earlier this year. Under the agreement, the generic will launch in the second half of 2009 and Ranbaxy will retain 180-day exclusivity.
GSK's U.S. Patent No. 4,957,924 covers the composition of Valtrex, a hydrochloride salt of the L-valyl ester prodrug of acyclovir. The generic form is referred to as valacyclovir. Patent protection was set to expire in late June 2009. Therefore, it does not appear that the settlement will lead to an early launch of the generic. Details of the settlement have not been released.
The Paragraph IV action had originally been filed in May 2003 in the District of New Jersey. A bench trial before Judge Mary Cooper was set to begin on July 18, but had been delayed until September at the parties’ request.
Ranbaxy’s stock rose 10% last week on the announcement of its 2009 entry into this lucrative product market.