Keywords: Ranbaxy, Glaxo, Valtrex, genital herpes

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

Article | 27 November 2009

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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.

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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.

The latter stems from the resolution of a dispute with Glaxo in 2007. Glaxo had charged Ranbaxy with infringing its Valtrex patent four years earlier and the Indian company countersued. The upshot was that Glaxos patent would endure until late December 2009 while Ranbaxy would receive marketing exclusivity for its generic version. The altercation has also led to some co-development agreements between the two.

Analysts are pencilling in about $175-$200m of sales for Ranbaxy during the exclusivity period. That looks like a conservative estimate, says Vikas Dandekar, the India Bureau Chief of PharmAsiaNews.com. There is big upside for Ranbaxy. It will be a clean play for the company; the big thing is there is no authorised generic as yet.This is one of the most eagerly awaited drug launched by Ranbaxy.

People had doubts about Ranbaxys first-to-file status pipeline being secure due to the FDA issues, said another analyst. Valtrex being launched on time means that they are well in control of the situation. It restores confidence in their FTFs since previously their FTF launch of generic Imitrex [a migraine treatment] was delayed by five months.

Analysts now also think that Ranbaxy could well beat its forecast of a huge loss for the year, noted The Times of India. For the nine months to the end of September, it has already eked out a small profit of $10m.