Source: The Journal News
Date: 9 January 2004

Barr gets tentative OK
for narcolepsy drug


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.

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.
further reading

Product Info
Caphalon, Inc
BLTC Research
The Good Drug Guide
Teva Pharmaceuticals
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