Teva and Merck agree on generic Temodar launch
Teva Pharmaceutical Industries Ltd. said Wednesday it agreed to hold off on launching a generic version of Merck & Co.'s cancer drug Temodar until a federal appeals court weighs in on the drug's patent.
Instead of launching its generic version of Temodar now, Teva said it will begin selling its drug only if the court agrees that a patent on the brain cancer drug is unenforceable. In return, Merck agreed to allow Teva to start selling its generic in August 2013 if the patent is upheld. At that time, Merck will still have pediatric exclusivity on the brain cancer treatment.
Merck sued Teva for patent infringement after Teva applied for approval of its generic version of Temodar. In February, a U.S. district court said the patent supporting Temodar was unenforceable. That ruling cleared a path for Teva, the world's largest generic drugmaker, to begin selling its version of the drug. Temodar, or temozolomide, was approved by the Food and Drug Administration in 1999.
Temodar was developed by Schering-Plough Corp. and the generic was developed by Barr Pharmaceuticals. Merck bought Schering-Plough in November, and Teva acquired Barr in late 2008.
In afternoon trading, shares of the Israeli company fell 35 cents to $59.99. Shares of Merck, based in Whitehouse Station, N.J., lost 30 cents to $37.64.