USFDA nod likely for Ranbaxy generic drug

NEW DELHI: The US drug regulator has opposed American firm Mylan Inc's request to strip Ranbaxy Laboratories of its six-month exclusive rights to sell a low-priced version of world's best-selling drug Lipitor in the US. The US Food and Drug Authority (FDA) has in principle allowed Ranbaxy to sell a generic version of the medicine from end of 2011, after original drugmaker Pfizer's patent expires in November. The six months headway can bring in as much as $500-600 million in revenues for India's largest drugmaker.

Last month, Mylan moved a local US court saying that FDA's approval to Ranbaxy should be quashed as the Indian firm isn't eligible for the marketing exclusivity since it submitted false and unreliable data from its Poanta Sahib plant, from where it has filed the application for its low-cost version of Lipitor. The FDA in its reply to the US court said it is for the regulator to determine if Ranbaxy's application should be approved or not. "US FDA has asked the court to dismiss Mylan's plea," a person familiar with the matter said.

Ranbaxy, now owned by Japan's Daiichi Sankyo, is yet to get final approval from the FDA for the drug even as it continues to work on a comprehensive settlement with the regulator.

A spokesman for US FDA said the regulator does not comment on pending drug application or lawsuits. Ranbaxy spokesman also declined comment.

Mylan is expected to launch its drug in May 2012. If Ranbaxy's exclusivity period is set aside, all generic makers of the medicine such as Mylan, Sandoz and Dr Reddy's can launch their low priced versions upon approval from the FDA. Following a settlement with Pfizer in mid 2008, Ranbaxy can launch its low-cost version of atorvastation calcium that sells under the original drugmaker's brand Lipitor ahead of others.