Top-selling statins finally going generic

Douglas Dawley, M.D.Douglas Dawley, M.D.
Cardiologist, Providence Heart and Vascular Institute

Published June 2011

The availability of generic drugs saves not only patients but the entire health care system substantial amounts of money.

From 2006 to 2010, the average monthly retail cost for a generic drug rose only 29 cents – from $20.60 to only $20.89. Over the same period, however, the cost of branded drugs doubled, from $91 a month to $187.

By the end of this year, patents will have expired for the two top-selling drugs in the world: Lipitor, with 2010 sales of $10.7 billion, and Plavix, with sales of $9.4 billion. Indian generic maker Ranbaxy has acquired the formula for Lipitor from Pfizer, and will begin making generic atorvastatin on Nov. 30, 2011.

Since the U.S. Food and Drug Administration allows the first generic manufacturer of a drug six months exclusivity, other generic manufacturers will not be allowed to compete in the marketplace until May 2012.

Still, patent law remains complex. Some of Pfizer’s additional patents on Lipitor don’t expire until 2015 and 2017, which could possibly make it more difficult for other generics to enter the market.

In any case, the addition of generic atorvastatin will have a big impact on the statin market. Even at 10 percent, the initial savings comes to $1 billion.

Clinical articles by Douglas Dawley, M.D.