Teva Pharma (TEVA) Sues FDA to Block Generic Copaxone (MYL)

May 9, 2014 2:21 PM EDT

(Updated - May 9, 2014 2:34 PM EDT)

Teva Pharma (NYSE: TEVA) sued the U.S. FDA over generic COPAXONE.

In March, Teva announced that the U.S. Supreme Court has granted the Company’s COPAXONE certiorari petition and will hear its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808. The 808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE (glatiramer acetate injection) 20mg/mL.

The Supreme Court later rejected Teva's move to block generic versions of COPAXONE in the appeal.

With the latest suit, Teva claims that the FDA is failing to respond to a request for generic trials.

On watch today also includes Mylan Inc. (Nasdaq: MYL). Teva is down 2 percent.



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