US pharmaceutical company Eton Pharmaceuticals (Nasdaq:ETON) announced on Friday that the United States Patent and Trademark Office has granted US Patent No. 12,214,010 for ET-600, a proprietary formulation of desmopressin oral solution.
The patent, which expires in 2044, is expected to be listed in the US Food and Drug Administration's Orange Book upon product approval. An additional patent application for ET-600 remains under review.
ET-600 is in development for diabetes insipidus, a rare condition affecting approximately 3,000 paediatric patients in the United States. There is currently no FDA-approved oral liquid formulation of desmopressin, leaving patients reliant on tablets, injections, nasal sprays or unapproved compounded liquid suspensions.
ET-600 previously passed a pilot bioequivalence study in 2024 and is undergoing a pivotal bioequivalence study, with results expected by the end of February. If successful, Eton Pharmaceuticals plans to file a New Drug Application with the FDA in the second quarter of 2025.
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