Rumblings of a settlement between Ranbaxy Laboratories and the FDA have sent the Indian company's stock upward as investors rub their hands over the prospect of an actual, for-real, not-just-promised launch of copycat Lipitor later this week. Ranbaxy has all but nailed down a $350 million to $400 million deal with the U.S. agency, India's Economic Times reports. Such a deal would resolve its long-outstanding manufacturing issues and clear the way for FDA approval for its generic version of the megablockbuster cholesterol drug.
Citing anonymous sources, the Times said Ranbaxy and the FDA could put the final touches on a settlement this week. Ranbaxy itself wouldn't comment, although company officials have been vowing to launch their Lipitor generic "on schedule" as exclusivity ends Nov. 30. The only hitch is the FDA hasn't approved Ranbaxy's copy, and to get approval, it apparently needs to wrap up negotiations with the agency. Thanks to quality control problems and allegedly falsified data, Ranbaxy drugs made at two Indian plants have been under an FDA import ban since 2008.
Ranbaxy has the coveted first-to-file status for its Lipitor copy, giving the company 180 days as the only independent generic rival to the Pfizer ($PFE) brand. U.S.-based Watson Laboratories ($WPI) has the rights to sell an authorized generic, while Pfizer has been aggressively working to keep patients on the branded version. Pfizer is offering discounts to patients and payers alike, putting generic-level prices on Lipitor in hopes of hanging on to roughly 40% of its current sales.
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