Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Eton Pharmaceuticals submitted a New Drug Application (NDA) for ET-400, a hydrocortisone oral solution with patent protection through 2043. The company expects potential approval by Q1 2025, aiming for combined peak sales of over $50 million annually.
ET-400 NDA submission made to FDA for potential approval by Q1 2025.
ET-400 and Alkindi Sprinkle® project combined peak sales exceeding $50 million annually.
ET-400 patent protection in place until 2043.
- None.
Insights
The submission of a New Drug Application (NDA) by Eton Pharmaceuticals for ET-400, a hydrocortisone oral solution, represents a critical milestone in the company's strategic plan. If approved by the FDA, ET-400, alongside Alkindi Sprinkle®, has the potential to generate significant revenue streams for Eton Pharmaceuticals. The anticipation of a 10-month review process suggests that investors can expect pivotal news regarding market entry by the first quarter of 2025.
From a financial perspective, the estimation of more than
The patent aspect of Eton Pharmaceuticals' strategy is vital for its potential market exclusivity and ability to set pricing without immediate generic competition. Patent protection for over two decades is exceptional and could result in sustained profitability for Eton if ET-400 is approved. Investors should be cognizant of the importance of intellectual property in the pharmaceutical industry, especially for smaller companies like Eton that focus on niche markets.
While patent issuance is positive, investors should also monitor ongoing patent applications, as they could further reinforce the company's intellectual property portfolio and provide additional layers of protection and value.
From a clinical standpoint, the unique formulation of a hydrocortisone oral solution, tailored for children with rare diseases, addresses an unmet medical need. Success in the pharmaceutical market is not just about invention but also about market demand and the medication's impact on patient care. The confidence expressed by Eton in strong demand from patients, caregivers and physicians for ET-400, indicates a well-vetted market need.
Investors should consider the therapeutic benefits and patient populations when evaluating Eton's potential market success post-approval. Future clinical data and real-world efficacy will be the true test of ET-400's market viability and, consequently, its impact on the company's financial health.
- Company anticipates 10-month review for potential approval in Q1 2025 -
- Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than
- Product has patent protection through 2043 -
DEER PARK, Ill., April 30, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton’s proprietary patented formulation of hydrocortisone oral solution. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.
“With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need. We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than
Eton has been issued a patent by the U.S. Patent and Trademark Office on ET-400, which expires in 2043 and has additional patent applications under review.
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.
FAQ
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