Eton Pharmaceuticals Bolsters Intellectual Property Portfolio with New U.S. Patent for ET-600

Eton Pharmaceuticals (ETON) has received a significant boost to its intellectual property portfolio with the issuance of U.S. Patent No. 12,214,010 for its proprietary formulation of desmopressin oral solution, ET-600. This patent, which expires in 2044, provides market exclusivity for the product and is expected to be listed in the FDA Orange Book upon approval. The Company has an additional patent application related to ET-600 under review with the USPTO.

ET-600 is a proprietary formulation of desmopressin oral solution under development for the treatment of diabetes insipidus, a rare condition characterized by excessive urine production and dehydration. Currently, desmopressin is only FDA-approved in injectable, tablet, and nasal forms, none of which fully meet the pediatric need for small, precise, and titratable doses. As a result, most pediatric patients rely on unapproved liquid suspensions from compounding pharmacies or attempt to cut and measure fractional tablets.

"This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "The pediatric endocrinology community has expressed the significant need for a liquid form of desmopressin that can accurately and efficiently deliver small doses for children, and we are proud to have developed a formulation to meet their needs and to see our innovation recognized with a patent."

ET-600 previously passed a pilot bioequivalence study in 2024 and is currently undergoing its pivotal bioequivalence study. The Company expects to have study results at the end of February. If results are positive, the company anticipates filing a New Drug Application (NDA) with the FDA for the product by the second quarter of 2025.

The issuance of this patent represents a crucial milestone for Eton Pharmaceuticals, securing market exclusivity through 2044. This timing is particularly strategic as it precedes the anticipated NDA filing in Q2 2025, establishing a robust IP protection framework before commercialization. The patent's scope covering the proprietary oral solution formulation addresses a significant market gap in pediatric diabetes insipidus treatment, creating substantial liability and efficacy concerns with current treatment options.

The upcoming listing in the FDA Orange Book upon product approval will provide additional layers of protection by requiring generic competitors to file Paragraph IV certifications and face potential 30-month stays on approval. This further strengthens Eton's market position and extends its revenue-generating potential.

Eton Pharmaceuticals' development strategy demonstrates careful market positioning, utilizing the bioequivalence pathway to reduce development risks and costs compared to new molecular entities. Targeting an established active ingredient (desmopressin) with proven efficacy minimizes regulatory hurdles, while the focus on pediatric formulation may qualify for additional exclusivity periods. With an additional patent application under review, Eton is building a comprehensive IP portfolio that could effectively block generic competition for over two decades.

The market opportunity, while niche, represents a high-value proposition given the current reliance on compounding pharmacies and the critical need for precise pediatric dosing in diabetes insipidus treatment. Eton Pharmaceuticals' strategic approach to intellectual property protection and market positioning positions the company to capture a significant portion of the market share and generate substantial revenue from ET-600 sales.



In conclusion, Eton Pharmaceuticals' issuance of U.S. Patent No. 12,214,010 for ET-600 represents a significant milestone in the company's intellectual property portfolio and market positioning. With market exclusivity through 2044 and a strategic approach to development, Eton Pharmaceuticals is well-positioned to capture a significant portion of the diabetes insipidus treatment market and generate substantial revenue from ET-600 sales.