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Generic Atorvastatin Now Available in US

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Generic Atorvastatin Now Available in US

Sue Hughes
Authors and Disclosures

Posted: 12/01/2011

December 1, 2011 (Princeton, New Jersey) — The US FDA has approved the first generic version of atorvastatin--from Ranbaxy Laboratories. The generic is now available as 10-mg, 20-mg, 40-mg, and 80-mg tablets, manufactured by Ohm Laboratories [1].

Ranbaxy has exclusivity to market generic atorvastatin until May 2012, after which time many more generic versions will become available.

Atorvastatin has until now been available only as the branded Lipitor (Pfizer), which has been the world's top-selling drug for several years. Last year, it had worldwide sales of $10.7 billion, of which $7.9 billion were in the US.

In an effort to keep some of its market share, Pfizer is producing an "authorized generic" product that is being marketed by Watson Pharmaceuticals. Pfizer has also agreed to deals with pharmacy-benefit managers to keep dispensing Lipitor for a time at generic prices. It has also launched a "Lipitor for you" program, which includes a card limiting a patient's copayment to $4, valid until the end of 2012, with the company reimbursing the pharmacy the remaining copayment value.

Patients will benefit enormously from the availability of the lower-cost generics, with many more now being able to afford to take atorvastatin, which is a more potent statin than others that have been available generically. Insured patients will also be better off, as the insurance copay for generic drugs is much cheaper than that for branded drugs.

Dr William Boden (University at Buffalo Schools of Medicine, NY), recently told heartwire that the availability of generic atorvastatin should bring public-health benefits. "At the moment the most widely prescribed generic statin is simvastatin. This will now change to atorvastatin, as all those patients who can't afford the large copays on the branded product will be able to get it much cheaper. That means more people will be on a more powerful statin, and cholesterol levels in general should be lower."

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