Eton Pharmaceuticals Expands Patent Portfolio with Issuance of New U.S. Patent for ET-600
Eton Pharmaceuticals (ETON) has been granted U.S. Patent No. 12,214,010 for ET-600, its proprietary formulation of desmopressin oral solution, providing patent protection through 2044. The patent is expected to be listed in the FDA Orange Book upon product approval.
ET-600 is being developed for diabetes insipidus treatment, particularly addressing the unmet pediatric need for precise, titratable liquid doses. Currently, desmopressin is only FDA-approved in injectable, tablet, and nasal forms, forcing pediatric patients to rely on compounding pharmacies or attempt fractional tablet dosing.
The product successfully completed a pilot bioequivalence study in 2024 and is currently in pivotal bioequivalence testing, with results expected by end of February. If successful, Eton plans to submit a New Drug Application to the FDA by Q2 2025.
Eton Pharmaceuticals (ETON) ha ottenuto il Brevetto USA n. 12,214,010 per ET-600, la sua formulazione proprietaria di soluzione orale di desmopressina, che offre protezione brevettuale fino al 2044. Si prevede che il brevetto venga inserito nel FDA Orange Book una volta approvato il prodotto.
ET-600 è in fase di sviluppo per il trattamento del diabete insipido, affrontando in particolare il bisogno insoddisfatto pediatrico di dosi liquide precise e titolabili. Attualmente, la desmopressina è approvata dalla FDA solo in forme iniettabili, compresse e nasali, costringendo i pazienti pediatrici a fare affidamento su farmacie di preparazione o a provare dosaggi frazionati di compresse.
Il prodotto ha completato con successo uno studio pilota di bioequivalenza nel 2024 ed è attualmente in fase di test di bioequivalenza fondamentale, con risultati attesi entro la fine di febbraio. Se avrà successo, Eton prevede di presentare una New Drug Application alla FDA entro il secondo trimestre del 2025.
Eton Pharmaceuticals (ETON) ha recibido la patente de EE. UU. No. 12,214,010 para ET-600, su formulación propietaria de solución oral de desmopresina, proporcionando protección de patente hasta 2044. Se espera que la patente se incluya en el FDA Orange Book una vez que se apruebe el producto.
ET-600 está siendo desarrollado para el tratamiento de la diabetes insípida, abordando particularmente la necesidad pediátrica no cubierta de dosis líquidas precisas y ajustables. Actualmente, la desmopresina solo está aprobada por la FDA en formas inyectables, tabletas y nasales, obligando a los pacientes pediátricos a depender de farmacias de compuestos o intentar dosificaciones de tabletas fraccionarias.
El producto completó con éxito un estudio piloto de bioequivalencia en 2024 y actualmente se encuentra en pruebas de bioequivalencia fundamentales, con resultados esperados para finales de febrero. Si tiene éxito, Eton planea presentar una Nueva Solicitud de Medicamento a la FDA para el segundo trimestre de 2025.
Eton Pharmaceuticals (ETON)는 ET-600에 대한 미국 특허 제12,214,010을 취득하였으며, 이는 자사의 독점 제조한 데스모프레신 경구 용액 제형으로 2044년까지 특허 보호를 제공합니다. 해당 특허는 제품 승인 후 FDA 오렌지 북에 등록될 것으로 예상됩니다.
ET-600은 요붕증 치료를 위해 개발되고 있으며, 특히 소아를 위한 정확하고 조정 가능한 액체 용량에 대한 충족되지 않은 필요를 다루고 있습니다. 현재 데스모프레신은 주사제, 정제 및 비강 제형으로만 FDA 승인을 받았으며, 이는 소아 환자들이 조제약국에 의존하거나 약을 나누어 복용해야 하도록 강요합니다.
이 제품은 2024년에 파일럿 생물학적 동등성 연구를 성공적으로 완료하였으며 현재 매우 중요한 생물학적 동등성 테스트 중에 있으며, 결과는 2월 말까지 예상됩니다. 성공할 경우 Eton은 2025년 2분기까지 FDA에 신약 신청서를 제출할 계획입니다.
Eton Pharmaceuticals (ETON) a obtenu le brevet américain n° 12,214,010 pour ET-600, sa formulation propriétaire de solution orale de desmopressine, offrant une protection par brevet jusqu'en 2044. Il est prévu que le brevet soit inscrit dans le FDA Orange Book après l'approbation du produit.
ET-600 est en cours de développement pour le traitement du diabète insipide, en répondant particulièrement au besoin pédiatrique non satisfait de doses liquides précises et titrables. Actuellement, la desmopressine n'est approuvée par la FDA que sous forme injectable, de comprimés et nasale, obligeant les patients pédiatriques à se fier aux pharmacies de composition ou à essayer des dosages de comprimés fractionnés.
Le produit a réussi à compléter une étude pilote de bioéquivalence en 2024 et est actuellement en phase de tests de bioéquivalence décisifs, avec des résultats attendus d'ici fin février. Si cela réussit, Eton prévoit de soumettre une nouvelle demande de médicament à la FDA d'ici le deuxième trimestre 2025.
Eton Pharmaceuticals (ETON) hat das US-Patent Nr. 12,214,010 für ET-600, seine proprietäre Formulierung einer desmopressin-haltigen oralen Lösung, erhalten, das bis 2044 Patentschutz bietet. Es wird erwartet, dass das Patent nach der Genehmigung des Produkts im FDA Orange Book aufgeführt wird.
ET-600 wird zur Behandlung von Diabetes insipidus entwickelt, insbesondere zur Deckung des ungedeckten Bedarfs bei pädiatrischen Patienten nach präzisen, titrierbaren Flüssigkeitsdosen. Derzeit ist Desmopressin nur in injizierbarer, Tabletten- und Nasenform von der FDA zugelassen, was pädiatrische Patienten zwingt, auf Rezeptur-Apotheken angewiesen zu sein oder versuchte, fraktionierte Tablettendosen zu nehmen.
Das Produkt hat 2024 erfolgreich eine Pilotstudie zur Bioäquivalenz abgeschlossen und befindet sich derzeit in den entscheidenden Bioäquivalenztests, deren Ergebnisse bis Ende Februar erwartet werden. Im Erfolgsfall plant Eton, bis zum 2. Quartal 2025 einen New Drug Application bei der FDA einzureichen.
- Patent protection secured until 2044 for ET-600
- Additional patent application under review with USPTO
- Successful completion of pilot bioequivalence study in 2024
- Addresses unmet market need in pediatric diabetes insipidus treatment
- Product still requires FDA approval
- Pivotal bioequivalence study results pending
- NDA submission not expected until Q2 2025
Insights
The issuance of patent No. 12,214,010 for ET-600 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. Current treatment options force practitioners to either compound unauthorized liquid formulations or attempt imprecise tablet splitting, creating substantial liability and efficacy concerns. The upcoming Orange Book listing, upon FDA approval, will provide additional layers of protection by requiring generic competitors to file Paragraph IV certifications and face potential 30-month stays on approval.
The development strategy shows careful market positioning:
- Bioequivalence pathway reduces development risks and costs compared to new molecular entities
- Targeting an established active ingredient (desmopressin) with proven efficacy minimizes regulatory hurdles
- 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.
- Product has patent protection through 2044 -
- Expected to be listed in the U.S. Food and Drug Administration’s (FDA) Orange Book upon the product’s approval –
DEER PARK, Ill., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 12,214,010, covering its ET-600 product candidate’s proprietary formulation of desmopressin oral solution. The patent expires in 2044 and is expected to be listed in the FDA Orange Book upon the product’s approval. The Company has an additional patent application related to the product under review with the USPTO.
ET-600 is a proprietary formulation of desmopressin oral solution under development for the treatment of diabetes insipidus. Desmopressin is the standard of care for diabetes insipidus, but there is not an FDA-approved oral liquid formulation. Currently, desmopressin is only FDA-approved in injectable, tablet, and nasal form, none of which fully meet the pediatric need for small, precise, and titratable doses. As a result, most pediatric patients use unapproved liquid suspensions from compounding pharmacies, attempt to cut and measure fractional tablets, or take daily injections.
“This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations. 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,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
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.
About Diabetes Insipidus
Diabetes insipidus is a rare condition in which the body produces too much urine and is not able to retain water. If left untreated, diabetes insipidus can cause excessive dehydration and delayed or stunted growth in children. The condition is estimated to affect about 1 in 25,000 people, or approximately 3,000 pediatric patients in the United States.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals, Inc.
FAQ
When does Eton Pharmaceuticals' new patent for ET-600 expire?
What is the current status of ET-600's clinical development?
When does ETON plan to file the New Drug Application for ET-600?
What medical condition is ET-600 being developed to treat?
Why is ET-600 significant for pediatric diabetes insipidus patients?
