Core Insights - Eton Pharmaceuticals has received U.S. Patent No. 12,214,010 for its ET-600 product candidate, a proprietary formulation of desmopressin oral solution, which is expected to be listed in the FDA's Orange Book upon approval and will remain protected until 2044 [1][3] - ET-600 is being developed specifically for the treatment of diabetes insipidus, addressing a significant unmet need in pediatric care, as current FDA-approved forms do not cater to the precise dosing requirements for children [2][5] - The company is currently conducting a pivotal bioequivalence study for ET-600, with results anticipated by the end of February 2025, and plans to file a New Drug Application (NDA) with the FDA in the second quarter of 2025 if results are favorable [4] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, with a portfolio that includes seven commercial products and four additional candidates in late-stage development [6]
Eton Pharmaceuticals Expands Patent Portfolio with Issuance of New U.S. Patent for ET-600