FDAnews Drug Daily Bulletin

PROVIGIL GRANTED PEDIATRIC EXCLUSIVITY

April 6, 2006
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The FDA has granted six months of pediatric exclusivity for Cephalon's narcolepsy drug Provigil, a move that could delay generic competition on the drug until 2012, the company said.

The patent extension covers Provigil (modafinil) tablets through April 6, 2015. But under previous settlement agreements, four generic drugmakers are poised to launch the product in April 2012, the company added. The generic firms could have launched the generic version in October 2011 if Cephalon had not received pediatric exclusivity.

Under deals forged in 2005 and 2006, Cephalon granted nonexclusive, royalty-bearing rights to Teva Pharmaceutical, Mylan Pharmaceuticals, Ranbaxy Laboratories and Barr Pharmaceuticals for the product in the U.S. The firms could still launch generic Provigil before April 2012 if another generic enters the market.

The FTC has asked Cephalon for information about the settlements, the firm said in its annual SEC report filed March 13. The FTC, Department of Justice or a private party could challenge any or all of the settlements in an administrative or judicial proceeding if they believe the agreements violate antitrust laws, Cephalon said, adding that there are no assurances the company could successfully defend against such a challenge.