Daiichi Sankyo subsidiary Ranbaxy Laboratories says it will launch its generic version of Pfizer's blockbuster cholesterol-lowerer Lipitor in the USA as planned on November 30.
The company's chairman Tsutomo Une confirmed the scheduled launch date in an interview with the Japanese Nikkei newspaper, in which he refuted speculation that Ranbaxy would cede control of its six-month exclusivity period for generic Lipitor (atorvastastin), which was agreed with Pfizer in 2008.
There had been suggestions that US Food and Drug Administration investigations into quality standards at Ranbaxy's manufacturing facilities could result in it being unable to introduce the generic on schedule.
Towards the end of 2009, the FDA sent Ranbaxy a warning letter saying it had not taken adequate measures to correct deficiencies at three facilities in its manufacturing network, and ordering the drugmaker to undertake a review of its entire manufacturing network. An import ban on product made at two Indian facilities remains in force, while the third, US plant is in the process of being closed down.
It has been estimated that Ranbaxy will rake in $500 million or more during the six-month grace period as it captures market share from Lipitor, which made more than $5 billion in US sales last year.
The Indian drugmaker will however not have the generic market to itself. Watson Pharmaceuticals has a separate deal with Pfizer to launch an authorised Lipitor generic beginning on November 30.