FDA approves Plavix as a generic

A scientist for the French firm Sanofi-Aventis, which made and marketed the blood-thinner with Bristol-Myers Squibb. Associated Press
A scientist for the French firm Sanofi-Aventis, which made and marketed the blood-thinner with Bristol-Myers Squibb. Associated Press
Posted: May 19, 2012

Plavix, the brand name for the blood-thinning drug taken by millions of people with heart disease to avoid heart attacks and strokes, will soon be on pharmacy shelves in generic form.

The U.S. Food and Drug Administration gave approval to the generic versions this week.

Plavix, whose generic name is clopidogrel, was made and marketed through a partnership of Sanofi-Aventis and Bristol-Myers Squibb. It had U.S. sales of about $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health. The companies will try to retain sales revenue through some discounting.

The drug is for people who already have some history of heart disease and need to avoid clotting problems that might lead to further heart attacks or a stroke.

Pittsburgh-based Mylan Pharmaceuticals was the first to file an application for generic approval so it will have six months as the only generic on the market. Mylan said in a statement that it would begin shipping tablets immediately.

After six months, other companies can sell versions, so the generic prices will drop more then.

The FDA said Teva Pharmaceuticals (with Americas headquarters in North Wales), Dr. Reddy’s Laboratories, Gate Pharmaceuticals and Mylan were approved for 300-milligram tablets of clopidogrel. Teva, Apotex Corp., Aurobindo Pharma, Mylan, Roxane Laboratories, Sun Pharma and Torrent Pharmaceuticals got approval for the 75-milligram dosage.

Contact David Sell at 215-854-4506 or dsell@phillynews.com or Twitter @PhillyPharma. Read his PhillyPharma blog on philly.com.

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