May 17 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
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