Watson Pharmaceuticals is rubbing its hands together in anticipation of having the new market for generic Lipitor all to itself. The company expects to launch an authorized generic version of the megablockbuster cholesterol drug in November, and if all goes well for Watson--and poorly for rival Ranbaxy Laboratories--that version won't have any rivals for some time.
As the Wall Street Journal reports, Ranbaxy actually has the coveted 180-day exclusivity awarded to the first generic challenger on any drug. But that exclusivity doesn't apply to authorized generics. And Ranbaxy has been plagued by trouble. It's still negotiating with the FDA to lift a 2008 ban on 30 of its Indian-made generics, and it failed to get approval for its version of Astellas Pharma's Flomax in time to take advantage of that 180-day exclusivity window.
It's possible that Ranbaxy could flub its Lipitor copycat launch, too. And given that the exclusivity period would still apply, other generics wouldn't be able to come to market, either, leaving Watson with a wide-open field--and the ability to charge first-to-market prices. But Ranbaxy is already turning out its version of the cholesterol drug for the South African market, where it sells under the brand name Lipogen. The Indian company has almost 11 months to get its Lipitor act together.
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