Axsome settles SUNOSI patent litigation, allows generics starting 2040

Axsome Therapeutics Inc. (NASDAQ: AXSM) announced it has resolved all patent litigation related to its SUNOSI (solriamfetol) drug product, according to a company statement. The litigation arose from companies submitting applications to the Food and Drug Administration seeking approval to market generic versions of SUNOSI in the United States.

Under the settlement agreement, Axsome will grant five companies rights to sell generic versions of SUNOSI beginning September 1, 2040, if pediatric exclusivity is granted for the drug, or March 1, 2040, if no pediatric exclusivity is granted. The generic sales are subject to FDA approval and standard agreement conditions.

The company settled with the final remaining first-to-file generic applicant that had pending patent litigation related to SUNOSI. No other patent litigation relating to the drug remains pending.

Axsome stated it will submit the settlement agreement to the Federal Trade Commission and Department of Justice for review, as required by law.

SUNOSI is approved for treating excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. The settlement effectively extends Axsome's market exclusivity for the drug until 2040, providing approximately 14-15 years of additional protection from generic competition.

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