Eton Pharmaceuticals Awarded Second Patent for ET-400 (Hydrocortisone Oral Solution)
Eton Pharmaceuticals has been granted its second patent (U.S. Patent No. 12,133,914) for ET-400, a proprietary liquid hydrocortisone formulation. The patent, extending protection through 2043, covers the method of using hydrocortisone oral liquid formulations. This follows the first patent received in February 2024, with an additional patent application under review. The FDA has accepted the New Drug Application for ET-400 with a PDUFA target action date of February 28, 2025. If approved, ET-400 would become the only FDA-approved liquid formulation of hydrocortisone.
Eton Pharmaceuticals ha ottenuto il suo secondo brevetto (U.S. Patent No. 12,133,914) per ET-400, una formula liquida proprietaria di idrocortisone. Il brevetto, che estende la protezione fino al 2043, copre il metodo di utilizzo delle formulazioni liquide orali di idrocortisone. Questo segue il primo brevetto ricevuto nel febbraio 2024, con un'ulteriore domanda di brevetto attualmente in fase di revisione. La FDA ha accettato la domanda di nuovo farmaco per ET-400 con una data di azione target PDUFA del 28 febbraio 2025. Se approvato, ET-400 diventerebbe l'unica formulazione liquida di idrocortisone approvata dalla FDA.
Eton Pharmaceuticals ha recibido su segunda patente (U.S. Patent No. 12,133,914) para ET-400, una formulación líquida de hidrocortisona de propiedad. La patente, que extiende la protección hasta 2043, cubre el método de uso de formulaciones líquidas orales de hidrocortisona. Esto sigue a la primera patente recibida en febrero de 2024, con una solicitud de patente adicional en revisión. La FDA ha aceptado la Solicitud de Nuevo Medicamento para ET-400 con una fecha objetivo de acción PDUFA del 28 de febrero de 2025. Si se aprueba, ET-400 se convertiría en la única formulación líquida de hidrocortisona aprobada por la FDA.
이튼 제약은 ET-400이라는 고유한 액상 하이드로코르티손 제제에 대해 두 번째 특허(U.S. Patent No. 12,133,914)를 취득했습니다. 이 특허는 2043년까지의 보호를 연장하며 하이드로코르티손 액상 제제를 사용하는 방법을 다룹니다. 이는 2024년 2월에 수여된 첫 번째 특허에 이어진 것으로 추가 특허 신청이 검토 중입니다. FDA는 ET-400에 대한 새로운 약물 신청을 수락했으며 PDUFA 목표 행동 날짜는 2025년 2월 28일입니다. 승인을 받을 경우, ET-400은 FDA에서 승인된 유일한 하이드로코르티손 액상 제제가 됩니다.
Eton Pharmaceuticals a obtenu son deuxième brevet (U.S. Patent No. 12,133,914) pour ET-400, une formulation liquide de hydrochlorothiazide propriétaire. Le brevet, qui prolonge la protection jusqu'en 2043, couvre la méthode d'utilisation des formulations liquides orales de hydrochlorothiazide. Cela fait suite au premier brevet reçu en février 2024, avec une demande de brevet supplémentaire en cours d'examen. La FDA a accepté la demande de nouveau médicament pour ET-400 avec une date cible d'action PDUFA du 28 février 2025. Si approuvé, ET-400 deviendrait la seule formulation liquide d'hydrocortisone approuvée par la FDA.
Eton Pharmaceuticals hat sein zweites Patent (U.S. Patent No. 12,133,914) für ET-400, eine proprietäre flüssige Hydrocortison-Formulierung, erhalten. Das Patent, das den Schutz bis 2043 verlängert, betrifft die Methode zur Verwendung von oralen Flüssigkeitsformulierungen von Hydrocortison. Dies folgt auf das erste Patent, das im Februar 2024 erteilt wurde, während ein zusätzlicher Patentantrag zur Prüfung vorliegt. Die FDA hat den Antrag auf ein neues Medikament für ET-400 angenommen, mit einem PDUFA-Zieltermin für die Maßnahme am 28. Februar 2025. Wenn genehmigt, würde ET-400 die einzige von der FDA genehmigte flüssige Formulierung von Hydrocortison werden.
- Secured second patent protection through 2043 for ET-400
- FDA accepted New Drug Application with PDUFA date set
- Potential to be the only FDA-approved liquid hydrocortisone formulation
- None.
Insights
This second patent grant significantly strengthens ETON's intellectual property portfolio for ET-400, providing market exclusivity until 2043. The dual patent protection, combined with the pending third application, creates a robust barrier against potential competitors. The FDA's acceptance of the NDA and assigned PDUFA date indicates the application met basic filing requirements.
The potential market opportunity is notable as ET-400 would be the first FDA-approved liquid hydrocortisone formulation. This unique position, protected by patents, could allow ETON to capture significant market share in the pediatric and elderly patient segments where liquid formulations are preferred. The Orange Book listing upon approval will provide additional regulatory protection, making it more challenging for generic competitors to enter the market.
- Product has patent protection through 2043 -
- Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025 -
DEER PARK, Ill., Nov. 07, 2024 (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 Application No. 18/443,889, now U.S. Patent No. 12,133,914, for ET-400, a proprietary patented formulation of liquid hydrocortisone. The patent, which expires in 2043, covers a method of using hydrocortisone oral liquid formulations and is expected to be listed in the U.S. Food and Drug Administration’s (FDA) Orange Book upon the product’s approval. Eton received its first patent (US 11,904,046) for ET-400 in February 2024 and the Company has an additional U.S. patent application under review related to the product.
“We are pleased to have been granted a second patent for ET-400, further strengthening the IP protection of this important asset. Through our interactions with the patient community, we’ve seen firsthand the extensive need and desire for an FDA-approved liquid formulation of hydrocortisone,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
The FDA has accepted the Company’s New Drug Application (NDA) for ET-400 and has assigned the application a PDUFA target action date of February 28, 2025. If approved, ET-400 would be the only FDA-approved liquid formulation of hydrocortisone.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, 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
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