Big upside for Ranbaxy as it launches generic version of Glaxos herpes drug Valtrex

Ranbaxy Laboratories, Indias top drugmaker in terms of sales, has just launched a copycat version of Glaxos Valtrex (valacyclovir hydrochloride)an antiviral drug for treating genital herpes, cold sores and shinglesin the US. Valtrex boasts annual sales of $2.2bn in America. Following FDA approval for two dosages of the medicine, it is producing 500mg and 1 gm tablets.

Ranbaxy had been first to file (FTF) an application for a copycat version of Valtrex and was therefore granted 180-day marketing exclusivity for it. But there had also been jitters over whether Ranbaxy would be in a position to bring the drug to market in time to maintain its marketing exclusivity. Ranbaxy was planning to manufacture the drug at its Dewas plant, which along with its Poanta facility has been struggling to get accredited by the FDA.

The regulator has deemed the manufacturing facilities substandard and banned the supply of medicines from the two sites. However, Ranbaxy has managed to switch production of generic Valtrex to its US manufacturing facilityrun by its American subsidiary Ohm Laboratoriesand has thus salvaged the six-month exclusive opportunity.