Mylan confirms first-to-file patent challenge for Nuvigil generic

PITTSBURGH Drug maker Cephalon and its French subsidiary sued generic drug maker Mylan in connection with the latter’s filing of an approval application for a generic version of a sleep disorder drug, Mylan said Monday.

Cephalon filed a lawsuit in U.S. district courts in Delaware and the northern district of West Virginia after Mylan sought Food and Drug Administration approval for armodafinil tablets in the 50-mg, 150-mg and 250-mg strengths, a generic version of Nuvigil. Nuvigil is used to improve wakefulness in patients with obstructive sleep apnea and hypnea syndrome, narcolepsy and shift work sleep disorder.

Mylan said it was the first company to file for approval of a generic version of Nuvigil, meaning that it will have six months in which to compete directly with the branded version after the FDA grants final approval, under regulations governing generic drugs.

The New York Times reported Wednesday that Cephalon is seeking an additional approval for Nuvigil, as a preventive treatment for jet lag. Gaining the approval would allow it to extend its market exclusivity for the drug.

Nuvigil had sales of $42.3 million during the six-month period ending Sept. 30, according to IMS Health.