Eton Pharmaceuticals Secures New Patent for ET-600 Drug

Eton Pharmaceuticals Secures New Patent for ET-600 Drug

- Product has patent protection through 2044 -
- Expected to be listed in the U.S. Food and Drug Administration’s Orange Book upon the product’s approval –

Eton Pharmaceuticals, Inc. (“Eton”) (NASDAQ: ETON), a pioneering company in the pharmaceutical sector, is pleased to announce the awarding of a new patent by the United States Patent and Trademark Office (USPTO). This patent, numbered 12,214,010, covers the innovative formulation of the ET-600 product candidate, specifically its proprietary desmopressin oral solution, which is designed for treating diabetes insipidus and is valid through 2044.

The importance of this patent lies not just in its length of protection but also in the expected inclusion of ET-600 in the FDA’s Orange Book once the product receives approval. This milestone signifies Eton’s promise to advance and innovate in the treatment landscape for rare diseases.

Overview of ET-600 and Its Development

ET-600 is advancing towards becoming a crucial treatment option for diabetes insipidus, a rare condition that can lead to excessive urination and dehydration. Traditionally, desmopressin has been available primarily in injectable, tablet, and nasal forms; however, pediatric patients often require liquid formulations for smaller, precise doses. In many cases, they are forced to rely on unapproved liquid suspensions or make complicated adjustments to existing tablet forms.

“We are excited to see our efforts in developing ET-600 recognized with this patent. It reinforces our commitment to delivering innovative solutions for patients in need,” stated Sean Brynjelsen, CEO of Eton Pharmaceuticals. He highlighted the urgency expressed by the pediatric endocrinology community for an accessible and accurate liquid dosage form of desmopressin.

Clinical Advancements and Future Plans

Eton has successfully completed a pilot bioequivalence study for ET-600 in the past year and is currently engaged in a pivotal study to further validate its effectiveness. Results from this study are anticipated soon, and should they confirm positive outcomes, Eton plans to file a New Drug Application (NDA) with the FDA by the second quarter of the upcoming year.

Understanding Diabetes Insipidus

Diabetes insipidus is a condition characterized by the body’s inability to properly retain water, leading to excessive urination. If left untreated, it can result in severe dehydration and complications, especially in children. Approximately 3,000 pediatric patients in the U.S. are believed to affected by this rare but serious condition, which equates to about 1 in every 25,000 individuals.

About Eton Pharmaceuticals

Eton Pharmaceuticals is on the cutting edge of treating rare diseases, with a robust portfolio currently comprising seven commercially available products, including INCRELEX®, ALKINDI SPRINKLE®, and GALZIN®. Alongside these, the company is also advancing multiple candidates in late-stage development, including ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. Eton’s commitment to innovation continues to drive its research and development in this critical area.

Frequently Asked Questions

What is ET-600?

ET-600 is a proprietary formulation of desmopressin oral solution, aimed at treating diabetes insipidus, making treatment safer and more accessible for children.

Why is the new patent important?

The new patent protects the formulation of ET-600, ensuring Eton's exclusive rights and facilitating everything needed for product approval.

How does diabetes insipidus affect children?

Diabetes insipidus can lead to serious dehydration issues in children, affecting their growth and overall health if not treated properly.

What are the next steps for Eton Pharmaceuticals?

Eton plans to analyze the results of its pivotal bioequivalence study and may file a New Drug Application with the FDA depending on these outcomes.

What products does Eton currently offer?

Eton offers several products for rare diseases, including INCRELEX®, ALKINDI SPRINKLE®, and GALZIN®, and is actively developing additional candidates.

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