Breather for Ranbaxy in generic Lipitor case

Ranbaxy Laboratories has got a breather in its battle to launch the generic version of the world’s top-selling drug Lipitor in the US market.

The Gurgaon-based company, which holds the first-to-file (FTF) status on Lipitor that had sales of $7.27 billion in the US last year, was facing an awkward situation after US firm Mylan Labs filed lawsuits to stop its launch of the generic version of the cholesterol-lowering drug.

Mylan had said that Ranbaxy is ineligible for launching the generic version because it had falsified data from its manufacturing plants in India from where filing for generic Lipitor was made.

However, now the US Food and Drug Administration (FDA), has said that it is premature for Mylan to seek action as the regulatory body has not yet granted approval to any of the applications filed for generic Lipitor. It said it is still considering the applications and cannot decide on any exclusivity until an application is ready for approval.

The FDA also said it is in talks with Ranbaxy on the issue. A Ranbaxy spokesperson refused to comment.

However, industry experts say the FDA’s remark is a reprieve for Ranbaxy which, if manages to get the regulatory approval and successfully launch generic Lipitor by the scheduled November date, can earn $500-600 million in the six month period of exclusivity, during which, other than Pfizer, which is the innovator of Lipitor, no other player would be allowed entry.

“It is not a sure shot win for Ranbaxy, but it is not a fall either,” said Bhavin Shah, research analyst, Dolat Capital Market.

Ranjit Kapadia, vice-president, institutional research, HDFC Securities, said it is a court case and only time will tell in what direction it moves.

US is a major geography for Ranbaxy with about 24-25% of its sales coming from there. Successful monetisation of Lipitor and other products like Nexium, Diovan and Actos, can fetch Ranbaxy as much as $1.7 billion during the exclusivity period, say analysts.