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Breckenridge Pharmaceutical to release Nuvigil generic

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BOCA RATON, Fla. — Breckenridge Pharmaceutical Inc. is launching armodafinil tablets (CIV), a medication for promoting wakefulness.

Breckenridge said this week that its armodafinil product, which comes in strengths of 50 mg, 150 mg and 250 mg, is a generic version of Nuvigil from by Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd.

Plans call for Breckenridge to launch its armodafinil tablets with partner Natco Pharma Ltd., which is the owner of the Abbreviated New Drug Application (ANDA) for the product. Breckenridge said it has entered into a confidential settlement with Cephalon that a includes a license to market its ANDA 180 days after the initial launch of generic versions of Nuvigil.

Nuvigil tablets (armodafinil) are indicated to improve wakefulness in adults with excessive sleepiness related to obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD).

U.S. sales for branded and generic Nuvigil tablets totaled $516 million in the 12 months through September, according to IMS Health data reported by Breckenridge.


ECRM_06-01-22


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