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Mylan Files Suit Against FDA Over Generic Provigil

Mylan Inc. (MYL) has filed a lawsuit against U.S Food and Drug Administration, seeking to overturn its decision which awarded Teva Pharmaceutical Industries Ltd. (TEVA) an 180-days sole exclusivity for the generic version of Cephalon's Provigil.

Provigil is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to sleep disorders. According to IMS Health, Provigil had U.S. sales of about $1.1 billion for the full year ended December 31, 2011.

Mylan's subsidiary, Mylan Pharmaceuticals has filed the suit against FDA in the U.S. District Court for the District of Columbia.

Earlier Thursday, Teva said the FDA decided that its subsidiary Teva Pharmaceuticals USA is the sole first-to-file for both Orange Book patents listed for Provigil, and therefore Teva alone is entitled for the 180-day exclusivity.

Mylan alleged that Teva did not maintain valid paragraph IV (PIV) certifications as a result of its acquisition of Cephalon last year. Mylan's complaint states that after the acquisition of Cephalon, Teva could no longer infringe its own patents and therefore is not entitled to exclusivity based on patent certifications.

Mylan also alleged that FDA should have found that Mylan is the sole first filer on one of the Orange Book Patents for Provigil.

The complaint also says that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission did not contemplate the current outcome when it imposed its conditions on the Teva/Cephalon merger.

Mylan is seeking immediate equitable relief from the Court requiring FDA to approve Mylan's ANDA.

MYL is currently trading on the NYSE at $22.55, down 2.63%, on a volume of 3.6 million shares. TEVA is currently trading at $45.00, up $0.25%, on a volume of 1.36 million shares, on the Nasdaq.

by RTT Staff Writer

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