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Mylan, Pfizer Reach Epinephrine-Pen Settlement With Teva

Pfizer Inc., the world’s biggest drugmaker, and Mylan Inc. said they settled patent-infringement litigation with Teva Pharmaceutical Industries Ltd. over a device used to inject epinephrine during potentially fatal allergic reactions.

Under the confidential settlement, Petach Tikva, Israel-based Teva, the largest generic-drug maker, may begin selling a copy of the injector in mid-2015 or earlier, New York-based Pfizer and Canonsburg, Pennsylvania-based Mylan said in a statement today.

“Teva currently does not have tentative approval from the U.S. Food and Drug Administration” for its product, and sales are subject to that approval, Pfizer and Mylan said in the statement. The Teva agreement must also be reviewed by the U.S. Justice Department and the Federal Trade Commission.

In a separate statement today, Antares Pharma Inc. of Ewing, New Jersey, which makes small-needle injector systems, said that in connection with the settlement, it will supply Teva with injectors, if needed, for 2013 and 2014.

Teva was sued over the EpiPen device in federal court in Delaware in August 2009. The medicine is used for emergency treatment of reactions to insect bites, food or drugs.

Denise Bradley, a Teva spokeswoman, said the company had no comment on the settlement.

The case is King Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc., 09-CV-652, U.S. District Court, District of Delaware (Wilmington).

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