Barr Pharmaceuticals Inc. reported yesterday that it has received preliminary approval from the Food and Drug Administration to market a generic form of Modafinil tablets used to treat narcolepsy, a disease characterized by excessive daytime sleepiness.
Barr gets tentative OKBy DAVID SCHEPP
for narcolepsy drug
THE JOURNAL NEWS
Pomona-based Barr filed an application with the FDA in December 2002 to begin selling Modafinil 100 milligram and 200 milligram tablets.
Barr spokeswoman Carol Cox said the generic-drug maker won't have a product on the market any time soon because the application is subject to litigation.
Cephalon Inc., the maker of Provigil, the brand name for Modafinil, alleges Barr infringed its patent on the drug. A trial is scheduled for next January in the U.S. District Court of New Jersey.
Modafinil had annual sales of about $289 million, as of Nov. 30.
The Good Drug Guide
Modafinil (Provigil) : structure
Modafinil: The Kelli White Affair
Modafinil (Provigil) and Beyond
Big Pharma and Madison Avenue
Modafinil (Provigil): FDA endorses new uses
Modafinil / Provigil from Ranbaxy Laboratories