Saturday, September 1, 2012

Ranbaxy Wins FDA Approval for Generic Lipitor

Pfizer’s�(PFE) drug Lipitor is facing yet another rival.�The FDA announced Wednesday night that it has cleared Ranbaxy Laboratories to sell a no-name version of top-selling cholesterol medication�in the U.S. This puts India�s biggest drug maker in competition with Watson Pharmaceuticals (WPI), which launched its generic version of Lipitor Wednesday.

Watson and Ranbaxy are the only two drug makers selling generic Lipitor � also known as atorvastatin — in the U.S. for the next six months. Watson has an arrangement with Pfizer to sell an authorized generic version of Lipitor and share the profits. Ranbaxy was awarded sales exclusivity under U.S. federal law as it was the first successful generic challenger to Lipitor. It took investors by surprise this morning by announcing�that�it will share with generic drug giant Teva Pharmaceutical Industries (TEVA) profits�from six months of the�drug�s sales.

Ranbaxy�s ability to launch its version of generic Lipitor was called into question because quality control and data reporting issues delayed an FDA approval. Still, Pfizer executives told reporters earlier this week they expected Ranbaxy to launch its pill this week

Brand-name Lipitor lost its patent Wednesday. Pfizer is undertaking an aggressive campaign to retain sales for the next six months, striking bargains with PBMs and insurers to keep dispensing the drug at generic prices. Executives told reports earlier this week that surveys show�as many as one-third of Americans now taking Lipitor wish to keep taking the brand-name version and analysts see them keeping as much as 40% of prescriptions.

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