Ranbaxy Laboratories Ltd, India's top drug maker by sales, has launched the herpes treatment drug valacyclovir hydrochloride, a generic version of GlaxoSmithKline's Valtrex, in the United States with a 180-day marketing exclusivity, a company spokesman said in Bangalore today.
"Ranbaxy Pharmaceuticals has introduced valacyclovir hydrochloride in 500 mg and 1g tablets, having previously been granted U S Food & Drug Administration approval for these oral dosage forms," the spokesman said.
"Ranbaxy Pharmaceuticals, being the first to file and to successfully challenge the Valacyclovir patents, is the first generic pharmaceutical manufacturer entitled to offer an affordable alternative to the brand," the spokesman added.
Annual US sales for valacyclovir tablets stood at $2.2 billion, according to September data from market research firm IMS.
In 2007, Ranbaxy had settled a patent dispute with GlaxoSmithKline for the drug.
The molecule represents Ranbaxy's first major first-to-file (FTF) opportunity since its acquisition of Daiichi and its problems with the FDA last year. Ranbaxy's generic Valtrex launch comes even before GSK's patent on the drug expires on 23 December this year.
Analysts expect that the company to mop up around $200 million in sales during the six-month period, considering that there may be price erosion once the generic is launched in the market.
The FDA approval has been granted to Ranbaxy's US subsidiary Ranbaxy Pharmaceuticals for the product to be manufactured at its Ohm Laboratories. Earlier, the company had applied for approval from its domestic facility (possibly Dewas), which is facing an import ban from the FDA.
Recently, Ranbaxy's chief executive and managing director Atul Sobti had said in an interview that the company will protect and monetise its FTF opportunity.
With the launch, the company may beat its guidance of reporting a huge loss of around Rs700 crore for the year, analysts said. For the nine-month period ended 30 September, the company has already mopped a small profit of $10 million.