The companies have agreed to a deal allowing Unichem to introduce a generic version of Axsome’s sleep disorder medication Sunosi starting on June 30, 2042.


Summary: Axsome Therapeutics Inc has reached a settlement with Unichem Laboratories Ltd over patent litigation concerning Axsome’s product Sunosi (solriamfetol). The agreement allows Unichem to market a generic version of Sunosi starting June 30, 2042, pending certain conditions and potential extensions. The settlement will be reviewed by the US Federal Trade Commission and the Department of Justice, while similar litigations with other parties are ongoing.

Key Takeaways:

  • Axsome Therapeutics and Unichem Laboratories settled their patent litigation, allowing Unichem to sell a generic Sunosi starting June 30, 2042, with a potential extension for pediatric exclusivity.
  • The settlement agreement will be reviewed by the US Federal Trade Commission and the Department of Justice as required by law.
  • Axsome has similar pending patent litigations with other parties in the US District Court for the District of New Jersey.

Axsome Therapeutics In, a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, announced that it has entered into a settlement agreement with Unichem Laboratories Ltd, resolving patent litigation related to Axsome’s product Sunosi (solriamfetol). 

The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from Unichem’s submission of an Abbreviated New Drug Application to the US Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. 

The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042, date is also subject to potential extension for pediatric exclusivity.

As required by law, Axsome and Unichem will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review. 

Similar patent litigation brought by Axsome against other parties remains pending in the US District Court for the District of New Jersey.

Sunosi received US Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Axsome acquired Sunosi from Jazz Pharmaceuticals in 2022.

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