Aytu BioPharma has secured a patent term extension for its first‑in‑class antidepressant EXXUA (gepirone extended‑release tablets). The extension extends U.S. Patent No. 7,538,116, a method‑of‑use patent, through September 2, 2030, adding five years to the original term.
The extension was granted under 35 U.S.C. 156, which compensates for time lost during FDA regulatory review. The original patent, issued May 26, 2009, had its term adjusted under 35 U.S.C. 154(b) to expire September 2, 2025. The new extension pushes the expiration to 2030, extending protection beyond the drug’s New Chemical Entity exclusivity, which ends September 22, 2028.
EXXUA, approved by the FDA on September 28, 2023, is a selective serotonin 5‑HT1A receptor agonist that offers a novel treatment profile for major depressive disorder, potentially avoiding the sexual dysfunction and weight gain associated with many other antidepressants. The drug is slated for commercial launch in 2025.
The extension strengthens Aytu’s competitive moat and extends the expected revenue runway, supporting sustained growth in the U.S. major depressive disorder treatment market, which is projected to reach $9.59 billion by 2033. Aytu is also exploring additional intellectual‑property strategies to further extend exclusivity beyond 2030.
The company’s broader portfolio focuses on central nervous system disorders, and the patent extension is a significant regulatory win that enhances the long‑term value of its product pipeline.
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