May 17th, 2012

FDA Approves Generic Clopidogrel as Plavix Loses Patent Protection

For the second time in the past 6 months, a cardiology mainstay drug has lost patent protection and gone generic. Today, the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November, the best-selling drug of all time, Lipitor (atorvastatin), another cardiology mainstay, went off patent, though it wasn’t until earlier this month that multiple generics became available.

The FDA said that it had approved 300-mg formulations of clopidogrel from Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals and 75-mg formulations from Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals.

In recent years, the FDA approved two newer antiplatelet drugs that had been designed to take over the central role of Plavix in treating acute coronary syndromes. However, these drugs – prasugrel (Effient) and ticagrelor (Brilinta) – have been struggling in the marketplace and at this point appear very unlikely to command a significant share of the market.

One Response to “FDA Approves Generic Clopidogrel as Plavix Loses Patent Protection”

  1. Paul Schoenfeld, MD says:

    As a low cost generic I wonder if cardiologists will tend to keep stent patients on the drug for longer than recommended periods or even indefinitely. I wonder if it will be used indefinitely for CAD as ASA is used or if it will replace ASA.