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Cephalon's Provigil Avoids Patent Challenge From Sandoz

May 11, 2005

Cephalon has dodged a patent challenge against its top-selling drug Provigil, which was recently targeted by an abbreviated new drug application (ANDA) filed by Sandoz.

Cephalon said that Sandoz, the generic division of Novartis Pharmaceuticals, no longer intends to challenge Cephalon's U.S. particle-size Provigil (modafinil) patent. Instead, Sandoz plans to convert its ANDA for modafinil from a Paragraph IV certification to a Paragraph III certification, Cephalon said.

The effect of this conversion is that Sandoz will certify to the FDA that it does not intend to market a generic form of modafinil until Cephalon's patent on the drug expires in 2014, Cephalon said. In turn, Cephalon has agreed to drop its patent infringement lawsuit against Sandoz.

Provigil, a treatment for narcolepsy, was Cephalon's top-selling drug in 2004, generating sales of $439.7 million.