Barr gets provisional approval for narcolepsy drug

Thomas Thorne

Essential

Last update: February 20, 2023

narcolepsy drug

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By DAVID SCHEPP
THE DAILY NEWS

Barr Pharmaceuticals Inc. reported yesterday that it 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, based in Pomona, filed an application with the FDA in December 2002 to begin selling modafinil in 100- and 200-milligram tablets.

Barr spokeswoman Carol Cox said the generic drug maker won't have a product on the market anytime soon because the application is subject to litigation.

Cephalon Inc., the maker of Provigil, the brand name for Modafinil, alleges that Barr infringed the drug's patent. A trial is scheduled for next January in the Federal District Court of New Jersey.

Modafinil had annual sales of about $289 million, as of November 30.

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