U.S. FDA approves sale of generic Plavix

Thu May 17, 2012 2:59pm EDT

May 17 (Reuters) - U.S. health regulators approved on Thursday the sale of generic versions of the widely used blood clot preventer Plavix by Mylan Pharmaceuticals, Teva Pharmaceutical Industries Ltd and several other generic drugmakers.

Mylan, which received Food and Drug Administration approval to sell generic Plavix at doses of 300 milligrams and 75 mg, said it had already begun shipping the blood thinner, known chemically as clopidogrel.

Teva was also approved to sell clopidogrel at both doses.

Plavix, sold by Bristol-Myers Squibb and France's Sanofi, had been the world's second biggest selling prescription medicine for the past several years with annual revenue reaching about $9 billion at its peak. Pfizer's cholesterol fighter Lipitor, which had been the No. 1 seller, began facing generic competition late last year.

Bristol and Sanofi had been girding for the May 2012 loss of U.S. patent protection on their biggest revenue source for quite some time by seeking new drugs through acquisitions and licensing deals, while hoping for success of medicines being developed in their own labs as well.

Canada's Apotex Corp, which won FDA approval to sell clopidogrel at the lower dose, had forfeited its opportunity at six months of generic exclusivity after briefly selling its generic version in 2006 during an ongoing challenge to the Plavix patent that it eventually lost in court.

Bristol at the time said it lost about $1 billion in Plavix sales after Apotex flooded the market with its unauthorized generic.

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