Cephalon granted six months of pediatric exclusivity for Provigil

By Lisa Kerner

Erie, Pa., March 28 - Cephalon, Inc. said the Food and Drug Administration will extend market exclusivity of Provigil (modafinil) tablets [C-IV] an additional six months to April 6, 2015.

The company met the terms of an FDA written request to provide data from clinical studies examining the effect of Provigil in pediatric patients, according to a company news release.

Provigil is for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea and shift-work sleep disorder.

Under the terms of the previously announced settlements with four generic firms, Cephalon granted each a non-exclusive royalty-bearing right to market and sell a generic version of Provigil in the United States, effective April 2012.

Cephalon is an international biopharmaceutical company based in Frazer, Pa., dedicated to the discovery, development and marketing of products in four core therapeutic areas: central nervous system, pain, oncology and addiction.

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