Mylan Sues FDA to Overturn Teva Exclusivity for Provigil

Mylan Inc. sued the U.S. Food and Drug Administration to overturn a decision that gives Teva Pharmaceuticals Industries Ltd. 180-day exclusivity to market the generic version of the sleep-disorder drug Provigil.

Mylan also sued the secretary of health and human services and the commissioner of food and drugs, according to a filing in federal court in Washington. Mylan applied to the FDA for approval of its own Provigil generic and planned to start marketing it tomorrow.

Teva, based in Petach Tikva, Israel, acquired rights to Provigil through its acquisition of Cephalon Inc. Provigil, used to improve daytime wakefulness in people suffering from narcolepsy and sleep apnea, had U.S. sales of about $1.1 billion last year, Canonsburg, Pennsylvania-based Mylan said today in a statement, citing data from IMS Health.

The FDA’s decision blocks other companies from introducing generic versions of the drug. Mylan said in its complaint that Teva can’t be granted exclusivity because it didn’t maintain valid certifications when it purchased Cephalon. Federal law encourages generic-drug companies to challenge patents held by a branded-drug company, Mylan said.

“Upon acquiring such control of Cephalon, Teva no longer had standing to challenge the validity, unenforceability or infringement of patents that it indirectly owns,” Mylan said in the lawsuit.

Teva Spokeswoman

Denise Bradley, a spokeswoman for Teva, declined to comment on the suit.

Mylan wants the court to order the FDA to grant “immediate approval” of its application to market the generic drug.

Kathleen Sebelius is the secretary of health and human services, and Margaret Hamburg is the food and drug commissioner.

Mylan lost 57 cents, or 2.5 percent, to $22.59 at 4:30 p.m. New York time in Nasdaq Stock Market trading. Teva fell 17 cents to $45.06.

The case is Mylan Pharmaceuticals v. Sebelius, 12-00524, U.S. District Court, District of Columbia (Washington).

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