Axsome Therapeutics said it has settled all remaining patent litigation tied to Sunosi, ending a legal fight that had been centered on generic-drug applications.
The company said the settlement was reached with the last remaining first-to-file generic applicant, clearing the final outstanding case. Under the agreement, Axsome will allow five companies to launch generic versions of Sunosi no earlier than Sept. 1, 2040, if pediatric exclusivity is granted, or no earlier than March 1, 2040, if it is not.
That timeline is the key change in the release: the company moved from active patent litigation to a fully resolved position, with no Sunosi patent cases left pending. The settlement also defines the earliest possible generic entry date, which is set roughly 14 years from now under the no-pediatric-exclusivity scenario and about 14 years and three months from now if pediatric exclusivity is granted.
Axsome said it will submit the agreement to the Federal Trade Commission and the Justice Department for review, as required. Today the company's shares have moved 1.04% to a price of $224.47. For the full picture, make sure to review Axsome Therapeutics's 8-K report.
