Axsome Therapeutics and Hetero Labs Settle Patent Dispute Over SUNOSI

In a significant development for the central nervous system (CNS) therapeutics market, Axsome Therapeutics, Inc. (NASDAQ: AXSM) has reached a settlement agreement with Hetero Labs Ltd. over patent litigation concerning SUNOSI® (solriamfetol)—a treatment indicated for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.

The litigation originated from Hetero’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of SUNOSI in the United States. Under the terms of the agreement, Hetero will be allowed to launch its generic version no earlier than March 1, 2040. This date remains contingent upon FDA approval and customary conditions. As is standard practice, the settlement will undergo review by both the Federal Trade Commission (FTC) and the Department of Justice (DOJ).

Implications for Axsome

By deferring generic competition until at least 2040, Axsome secures over a decade of additional exclusivity for a product that fits squarely into its growing CNS-focused portfolio. SUNOSI is among several FDA-approved treatments developed by the company, alongside late-stage programs aimed at major depressive disorder, migraine, Alzheimer’s agitation, and more.

The company’s financial profile reinforces this growth narrative. Axsome Therapeutics closed 2024 with impressive growth, reporting total net product revenue of $385.7 million for the full year, an 88% increase over 2023, and $118.8 million for Q4 alone, up 66% year-over-year. SUNOSI made a significant contribution, with $94.3 million in full-year 2024 revenue, up 26% year-over-year, and $26.2 million in Q4, a 16% increase over the prior year.

Broader Litigation Landscape

While the resolution with Hetero helps reduce near-term litigation risk, Axsome continues to defend its IP rights against other ANDA filers regarding SUNOSI in the U.S. District Court for the District of New Jersey. This proactive approach reflects the company’s broader strategy: protecting its intellectual property while simultaneously scaling its commercial footprint.

 

For Axsome: Charles M. Lizza, William C. Baton, Sarah A. Sullivan, and Alexander L. Callo of Saul Ewing LLP, F. Dominic Cerrito, Eric C. Stops, Evangeline Shih, Gabriel P. Brier, Frank C. Calvosa, Brian J. Forsatz, Abigail E. DeMasi, and Shira M. Bergman of Quinn Emanuel Urquhart & Sullivan

For Hetero Labs: Kaan Ekiner of Cozen O’Connor

 

This article was assisted by AI and reviewed by the editor.