Axsome Therapeutics settles Sunosi patent litigation with Hikma

Axsome Therapeutics has entered into a settlement agreement with Hikma 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 submission by Hikma of an Abbreviated New Drug Application to the Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. 

Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after Sept. 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.

[Read more: Generic drug makers continue forging ahead]

As required by law, Axsome and Hikma will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties related to Sunosi remains pending in the U.S. District Court for the District of New Jersey.

[Read more: A new environment for biosimilars]