Generic Lipitor is on track. That's the word from Ranbaxy Laboratories, whose executives are promising the copycat version of Pfizer's ($PFE) mega-blockbuster cholesterol pill will hit the market Nov. 30 as planned. If that's the case, it dashes any hopes that Pfizer's Lipitor sales might get a temporary reprieve from generic competition.
Ranbaxy's ability to get FDA approval for its version of Lipitor has been in doubt for some time. The company has been working to square itself with U.S. regulators since the FDA found shortfalls at Indian plants back in 2008. The agency later put a cadre of Ranbaxy products under an import alert. Two of its plants have attracted special FDA scrutiny, including one in which Lipitor copies were reportedly scheduled for production. Without FDA clearance of the plant, Ranbaxy couldn't sell the drug.
As Ranbaxy officials repeatedly reported "progress" in negotiations with FDA, other generics makers got antsy. Anxious to sell its version of the drug, Mylan ($MYL) went so far as to sue the agency for the rights. That suit didn't get far, but Credit Suisse analysts recently put forward a theory that Ranbaxy might sell off its right to 180-day exclusivity for its version if it didn't get its act together in time.
But Chairman Tsutomu Une told Nikkei that the company's schedule for launching Lipitor is unchanged. Une also said the company wouldn't sell its marketing rights.
Meanwhile, Ranbaxy's Japanese parent, Daiichi Sankyo, is working with the FDA to resolve the problems with the two Indian plants--and to get the agency's OK for its Lipitor copy, a spokesman told Bloomberg. An Infinity analyst told the news service that the Lipitor launch promise indicates "that if they don't get the clearance for those two plants, they will take it up through the third plant that is operational."
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