New hopes for Ranbaxy to grab Lipitor pie

USFDA appeals for dismissal of objection, says decision later.

Ranbaxy’s hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.

According to reports, the USFDA in a petition filed in a California court had requested Mylan’s complaint be dismissed. “No immediate decision will be made on Ranbaxy's ANDA (abbreviated new drug application)”, the petition said.

Ranbaxy, which holds a first-to-file status on the cholesterol drug, can reap about $500-600 million in the six-months exclusivity period starting from November 2011, when the patent on Lipitor expires. Lipitor, developed by US-based Pfizer, had sales of $7.27 billion in the US in 2010, according to IMS Health.

On Thursday, Ranbaxy shares went up 0.15 per cent to touch Rs 463 on the Bombay Stock Exchange (BSE).

Last month, Mylan Inc had sued the FDA, questioning Ranbaxy's eligibility to launch the generic version of Lipitor, alleging of falsified data from Ranbaxy's manufacturing site in Himachal Pradesh from where generic Lipitor may be produced. A facility at Paonta Sahib in Himachal Pradesh is under FDA scanner since September 2008 for manufacturing irregularities.

“USFDA should allow other generic-drug makers, including Mylan, to launch generic version of Lipitor as soon as a patent expires," Mylan said in its complaint. The USFDA in its petition said no generic players have been given any final approval to launch generic Lipitor.

Ranbaxy has also not received final approval from the US FDA to launch the generic Lipitor, which is likely to be know only in November, when the patent expires.