Cephalon gains Provigil patent extension

The extra six months of exclusivity was granted after Cephalon met the terms of a written request to provide data from clinical studies examining the effect of Provigil in pediatric patients.

The food and drug administration modernization act of 1997 enables the FDA to issue written requests for pediatric studies to companies if the agency determines that information related to the use of an approved drug in pediatric patients may produce health benefits.

Cephalon previously announced its settlement with four generic firms of its patent infringement litigation concerning Provigil. Under the terms of the settlements, Cephalon granted to each of the four defendants a non-exclusive royalty-bearing right to market and sell a generic version of Provigil in the US, that will now become effective in April 2012, subject to earlier entry in certain circumstances.