Barr Gets Tentative OK For Narcolepsy Drug

Tomas Thorne

Last Updated: February 20, 2023

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.


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