Eton Pharmaceuticals Expands Patent Portfolio with New U.S. Patent for ET-600

Eton Pharmaceuticals, an innovative company specializing in treatments for rare diseases, has been granted a U.S. patent for its ET-600 product candidate. The patent, which secures protection until 2044, covers the proprietary formulation of a desmopressin oral solution and is expected to gain listing in the FDA's Orange Book once approved. Eton has also submitted an additional patent application related to this product, which is under review by the United States Patent and Trademark Office.

ET-600 focuses on treating diabetes insipidus, a rare disorder characterized by excessive urine production and difficulty retaining water. This condition affects approximately 1 in 25,000 individuals, including around 3,000 children in the United States. If not managed properly, it can lead to severe dehydration and can negatively impact growth in children. Desmopressin is the standard treatment for this condition, but existing FDA-approved options are limited to injectable, tablet, and nasal forms. None of these options adequately meet the needs of pediatric patients, who often require small, precise doses. As a result, many children rely on unapproved liquid suspensions from compounding pharmacies, fractional tablets, or daily injections.

The CEO of Eton Pharmaceuticals, Sean Brynjelsen, emphasized the importance of this patent in strengthening the company's intellectual property portfolio and addressing unmet needs in the pediatric endocrinology community. The new liquid formulation of desmopressin is designed to deliver accurate doses for children, marking a significant advancement for patients who have had limited options until now.

ET-600 has already passed a pilot bioequivalence study in 2024, and it is currently undergoing a pivotal bioequivalence study. Eton Pharmaceuticals expects to announce the results by the end of February. If the outcomes are favorable, the company is planning to file a New Drug Application (NDA) with the U.S. Food and Drug Administration in the second quarter of 2025.

Eton Pharmaceuticals continues to focus on developing and commercializing treatments for rare diseases. The company has seven commercial products catering to niche markets, including INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Besides ET-600, Eton is working on additional product candidates like ET-400, Amglidia®, and the ZENEO® hydrocortisone autoinjector, which are in advanced stages of development.

In conclusion, the patent approval for ET-600 is a pivotal step for Eton Pharmaceuticals as it continues to innovate in the realm of rare diseases. With the potential to offer a groundbreaking oral formulation for diabetes insipidus, particularly for pediatric patients, the company is poised to make a significant impact on an underserved patient population. The anticipated FDA filing further marks a critical phase in bringing this important treatment option closer to those who need it.