/publications/gpr/2006/GPR_2006-02/GPR_2006-02_3419

FDA Approves First Generic Plavix

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Generic manufacturer Apotex has received the green light from the FDA for its abbreviated new drug application for a generic version of Plavix (clopidogrel bisulfate). Plavix is a blood thinner designed to reduce the risk of heart attack, stroke, or vascular death in patients with established peripheral arterial disease. Apotex is not releasing details regarding the possible launch of the product, according to a company statement.

The company is currently facing a patent battle with Bristol-Myers Squibb, who markets the drug with Sanofi-Aventis SA. Apotex was the first generic to file with the FDA, and thereby entitled to 180 days of generic market exclusivity. The 2 drug manufacturers contend that their patents for Plavix are valid until 2011. A trial is set for April 2006.

"Apotex is confident that the patent will be held invalid and that an affordable generic alternative to Plavix will be available to consumers. We have been fighting for this for years and are committed to ensuring that the product comes to market as soon as the time is right,"said Barry Sherman, PhD, chief executive officer of Apotex, in a press statement.