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 formulaci贸n l铆quida de hidrocortisona de propiedad. La patente, que extiende la protecci贸n hasta 2043, cubre el m茅todo de uso de formulaciones l铆quidas orales de hidrocortisona. Esto sigue a la primera patente recibida en febrero de 2024, con una solicitud de patente adicional en revisi贸n. La FDA ha aceptado la Solicitud de Nuevo Medicamento para ET-400 con una fecha objetivo de acci贸n PDUFA del 28 de febrero de 2025. Si se aprueba, ET-400 se convertir铆a en la 煤nica formulaci贸n l铆quida de hidrocortisona aprobada por la FDA.
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Eton Pharmaceuticals a obtenu son deuxi猫me brevet (U.S. Patent No. 12,133,914) pour ET-400, une formulation liquide de hydrochlorothiazide propri茅taire. Le brevet, qui prolonge la protection jusqu'en 2043, couvre la m茅thode d'utilisation des formulations liquides orales de hydrochlorothiazide. Cela fait suite au premier brevet re莽u en f茅vrier 2024, avec une demande de brevet suppl茅mentaire en cours d'examen. La FDA a accept茅 la demande de nouveau m茅dicament pour ET-400 avec une date cible d'action PDUFA du 28 f茅vrier 2025. Si approuv茅, ET-400 deviendrait la seule formulation liquide d'hydrocortisone approuv茅e par la FDA.
Eton Pharmaceuticals hat sein zweites Patent (U.S. Patent No. 12,133,914) f眉r ET-400, eine propriet盲re fl眉ssige Hydrocortison-Formulierung, erhalten. Das Patent, das den Schutz bis 2043 verl盲ngert, betrifft die Methode zur Verwendung von oralen Fl眉ssigkeitsformulierungen von Hydrocortison. Dies folgt auf das erste Patent, das im Februar 2024 erteilt wurde, w盲hrend ein zus盲tzlicher Patentantrag zur Pr眉fung vorliegt. Die FDA hat den Antrag auf ein neues Medikament f眉r ET-400 angenommen, mit einem PDUFA-Zieltermin f眉r die Ma脽nahme am 28. Februar 2025. Wenn genehmigt, w眉rde ET-400 die einzige von der FDA genehmigte fl眉ssige 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 (鈥淓ton鈥� or the 鈥淐ompany鈥�) (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鈥檚 (FDA) Orange Book upon the product鈥檚 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.
鈥淲e 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鈥檝e seen firsthand the extensive need and desire for an FDA-approved liquid formulation of hydrocortisone,鈥� said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
The FDA has accepted the Company鈥檚 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庐, PKU GOLIKE庐, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO庐 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 鈥渇orward-looking statements鈥� 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鈥檚 business strategy, Eton鈥檚 plans to develop and commercialize its product candidates, the safety and efficacy of Eton鈥檚 product candidates, Eton鈥檚 plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton鈥檚 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 鈥渂elieves,鈥� 鈥渁nticipates,鈥� 鈥減lans,鈥� 鈥渆xpects,鈥� 鈥渋ntends,鈥� 鈥渨ill,鈥� 鈥済oal,鈥� 鈥減otential鈥� and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton鈥檚 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鈥檚 development programs and financial position are described in additional detail in Eton鈥檚 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 is the PDUFA date for Eton Pharmaceuticals' ET-400?
How long does Eton Pharmaceuticals' new patent protection for ET-400 last?
What makes Eton Pharmaceuticals' ET-400 unique in the market?
