FRAZER, Pa., March 28 (UPI) -- Cephalon said Monday the Food and Drug Administration extended market exclusivity for Provigil to 2015.
The additional six months of exclusivity were granted because Cephalon "met the terms of a written request to provide data from clinical studies examining the effect of Provigil in pediatric patients," the company said.
Provigil is indicated for improving wakefulness in patients with excessive sleepiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.
Cephalon previously settled a Provigil patent-infringement challenge with four generic firms under which it agreed to grant the companies a non-exclusive royalty-bearing right to market and sell a generic version of the drug in the United States. That agreement will now become effective in April 2012, Cephalon said.
