Having reached an agreement with GlaxoSmithKline (GSK), Ranbaxy Laboratories Ltd (RLL) on Thursday said it could now launch a generic version of GSK?s drug to treat herpes virus infection Valacyclovir Hydrochloride in the US by 2009-end.
As per the settlement, RLL would enjoy 180-day exclusivity to market the drug, which had sales of about $1.3 billion in 2006 in the US.
The two companies were fighting legal battle over GSK?s patent (4,957,924) covering Valacyclovir Hydrochloride and its use in the treatment of herpes virus infection. Earlier in February 2007, RLL had received a final approval from the US FDA to market and manufacture the drug in the US.
The news had an immediate impact on the company?s share price that went up by 9.49% at Rs 373.40 per share on Thursday at the Bombay Stock Exchange.
Settlement on the patent dispute puts Ranbaxy in a comfortable position as Valtrex, which is growing at about 15-20%, goes off patent in 2009.
The company might gain up to $400 million during the exclusivity period, said industry insiders. The company did not disclose the financial details of the settlement.
Analysts, however, said the company must have received money to go for an out-of-court settlement. Ranbaxy has first to file status on about 20 para IV abbreviated new drug approvals on varies patented drugs. Companies including Pfizer and GSK hold the patents. These first to file would help Ranbaxy secure exclusive marketing rights in the US worth about $26 billion before the entry of other generic companies, the company said in a statement.
First to file applications could bring generics companies handsome returns from the US as over 80 drugs with combined US sales of $95 billion are set to lose patent protection over the next six years. Ranbaxy sells generics of cholesterol-lowering drug Pravachol in 80 mg strength. It had won exclusive rights to market 80 mg tablets of simvastatin last year. In 2002, the company won similar rights to sell 125 milligram, 250 milligram and 500 milligram tablets of cefuroxime axetil used to treat infections in the chest, the urinary tract and the skin.