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Teva (TEVA) Getting Dose of Own Medicine in Copaxone Challenge

July 25, 2011 11:13 AM EDT
Teva Pharmaceutical (Nasdaq: TEVA) shares are seeing some pressure Monday as one of it's biggest moneymaking drugs is coming under fire.

Rival pharmas like Mylan (NYSE: MYL) and Momenta (Nasdaq: MNTA) are lobbying the U.S. Food and Drug Administration to sell copies of Teva's Copaxone ahead of multiple key expected patent expiration in 2014 and 2015. Mylan and Momenta plan to challenge the validity of the Copaxone patents.

The strategy is similar to a move previously used by Teva, and a large reason why the company has become one of the largest generic drug suppliers in the U.S. Starting off wholesaling drugs, Teva began to manufacture copies of drugs after WWII, when Israel limited imports. The company grew and grew through the use of patent challenges, and is now the 13th largest drug maker in the U.S.

To protect it's interest, Teva has sued the challengers for patent infringement, and requested the FDA require full-scale clinical trials, not typically necessary for generics, but a tactic drug makers use to protect their interests.

Teva has a big interest in protecting Copaxone. The MS treatment brings in nearly one-fifth of annual sales. Last year, Copaxone accounted for $3 billion of Teva's $16.1 billion in total revenue.

No word on when the FDA will make a decision on Copaxone. For now, all Teva investors can do is simply sit and wait.

Shares are down about 0.8 percent Monday.


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