Eton Pharmaceuticals has received a patent from the US Patent and Trademark Office (USPTO) for its ET-600 desmopressin oral solution.
This patent covers the proprietary formulation of ET-600, designed to treat a rare condition called diabetes insipidus.
The patent will expire in 2044 and is expected to be listed in the US Food and Drug Administration’s (FDA) Orange Book after approval.
Eton Pharmaceuticals also has an additional patent application associated with the product currently under review with the USPTO.
While desmopressin is the standard treatment, there is no FDA-approved oral liquid form.
Currently, desmopressin is only available in injectable, tablet, and nasal forms, which do not fully meet the paediatric population’s need for precise, small doses.
As a result, many paediatric patients rely on unapproved liquid suspensions, cut tablets, or daily injections, the pharmaceutical company said.
Eton Pharmaceuticals CEO Sean Brynjelsen said: “This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations.
“The paediatric 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 recognised with a patent.”
ET-600 successfully passed a pilot bioequivalence study in 2024 and is now undergoing its pivotal bioequivalence study.
The company expects results by the end of February. If the results are positive, Eton plans to file a new drug application (NDA) with the FDA by Q2 2025.
Eton Pharmaceuticals is focused on developing rare disease treatments. It currently markets seven rare disease products, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone.
The drug maker also has four late-stage product candidates in development, which include ET-400, ET-600, Amglidia, and the ZENEO hydrocortisone autoinjector.
Last month, Eton Pharmaceuticals acquired Galzin (zinc acetate) from Teva Pharmaceuticals USA. Galzin is an FDA-approved maintenance treatment for Wilson disease.
