SAN DIEGO — September 29, 2026
Acadia Pharmaceuticals Inc. announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application covering weight-banded dosing of trofinetide for the treatment of Rett syndrome. U.S. Patent Application No. 17/590,496, titled “Methods and Compositions for Treatment of Rett Syndrome,” has been determined to meet patentability requirements, with the patent expected to issue following completion of standard administrative procedures. Once issued and including six months of pediatric exclusivity, the patent is expected to provide protection for trofinetide in the United States through March 28, 2041, extending protection by almost five years beyond the existing July 2036 method-of-use patent..
Patent Covers Weight-Banded Trofinetide Dosing
The allowed patent application specifically covers weight-banded dosing of trofinetide, which is marketed in the United States as DAYBUE and DAYBUE STIX for the treatment of Rett syndrome in adults and pediatric patients aged 2 years and older. Weight-banded dosing is used to tailor administration according to a patient’s weight. The Notice of Allowance indicates that the USPTO has determined that the application satisfies the applicable patentability requirements, although the patent has not yet formally issued and remains subject to standard administrative steps. Acadia said the additional intellectual property protection strengthens its U.S. patent portfolio surrounding trofinetide and the current formulations of DAYBUE. The company expects the newly allowed patent, once issued, to extend U.S. protection from the current July 2036 expiration of its method-of-use patent into 2041.
Acadia Expands Intellectual Property Protection for DAYBUE
The expected patent term would extend trofinetide protection by nearly five years in the United States, providing additional intellectual property coverage for Acadia’s Rett syndrome franchise. The company said the allowance complements an existing method-of-use patent covering trofinetide for Rett syndrome, which currently expires in July 2036. Including six months of pediatric exclusivity, the newly allowed patent is expected to remain in force through March 28, 2041. DAYBUE was developed as a treatment for Rett syndrome, a rare neurodevelopmental disorder generally associated with mutations in the MECP2 gene. Trofinetide is a synthetic analog of the N-terminal tripeptide of insulin-like growth factor 1, although its mechanism of therapeutic action in patients with Rett syndrome remains unknown. The patent allowance concerns the dosing regimen rather than a change to the established mechanism of action.
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DAYBUE Remains Central to Rett Syndrome Portfolio
Acadia markets DAYBUE and DAYBUE STIX in the United States for adults and children 2 years of age and older with Rett syndrome, a rare condition characterized by developmental regression and neurological and motor impairments. Rett syndrome generally emerges after an initial period of apparently typical development, followed by loss or impairment of acquired communication and purposeful hand-use skills. Many patients require substantial long-term support and care. Trofinetide is designed for oral administration and is the active pharmaceutical ingredient in DAYBUE products. The company said the additional patent protection reflects its commitment to supporting current formulations and maintaining long-term intellectual property coverage for the therapy. The Notice of Allowance is an intellectual property milestone and does not represent a new regulatory approval or a change in the approved use of trofinetide.
Source :Acadia Pharmaceuticals press release
