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Egetis Therapeutics AB (publ) (Egetis), an innovative and integrated pharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) granted Patent No. US 12611383B1 for the company’s patent application No. 19/261,360 entitled “Pharmaceutical Compositions for Treating MCT8 Deficiency”.
The newly granted patent provides protection for a novel composition, which contains tiratricol as the active ingredient, designed to correct the disrupted thyroid hormone signalling characteristic of MCT8 deficiency. The claims cover, among other things, a method of treating MCT8 deficiency with the claimed pharmaceutical composition that encompasses tiratricol, dosing regiments, and tiratricol compositions with specific excipients. This patent represents a significant milestone in strengthening the company’s intellectual property portfolio. Egetis expects the granted patent will be Orange Book-listable. The patent has an expiration date of 2045.
Nicklas Westerholm, CEO, said: “The grant of this patent represents an important milestone in strengthening the intellectual property protecting Emcitate (tiratricol). If approved in the US, Emcitate is expected to benefit from statutory 7-year orphan drug exclusivity in addition to patent protection.”
As previously communicated, Egetis also intends to seek corresponding patent protection in additional territories around the World, including Europe and Japan, based on a PCT International Patent Application that the Company has filed.
Emcitate (tiratricol) has been granted Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Paediatric Disease Designations by the US Food and Drug Administration (FDA). On March 27, 2026, the FDA accepted the filing of Egetis’ New Drug Application (NDA) for Emcitate (tiratricol) for the treatment of MCT8 deficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 28, 2026.
Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
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