Eton Pharmaceuticals has announced the issuance of U.S. Patent No. 12,133,914 for ET-400, a patented liquid formulation of hydrocortisone. This second patent, set to expire in 2043, covers the method of using hydrocortisone oral liquid formulations. The FDA has accepted the New Drug Application (NDA) for ET-400, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.
Addressing Unmet Needs in Hydrocortisone Therapy
Hydrocortisone is a crucial medication for patients with adrenal insufficiency and other conditions requiring corticosteroid replacement. Currently, there is no FDA-approved liquid formulation of hydrocortisone. If approved, ET-400 would fill this gap, offering a more convenient and accurate dosing option, particularly for pediatric and elderly patients who may have difficulty swallowing tablets or capsules.
Intellectual Property and Market Exclusivity
The newly granted patent significantly bolsters Eton Pharmaceuticals' intellectual property position for ET-400. Combined with the first patent received in February 2024 (US 11,904,046) and a pending third patent application, the company aims to establish a strong barrier to entry for potential competitors. According to Eton, the patent, which expires in 2043, covers a method of using hydrocortisone oral liquid formulations and is expected to be listed in the FDA’s Orange Book upon the product’s approval.
Regulatory Pathway and Future Prospects
The FDA's acceptance of the NDA and assignment of a PDUFA date indicate that the application has met the necessary filing requirements. The PDUFA date of February 28, 2025, represents the target date for the FDA to complete its review of the application and make a decision on approval. "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.
About ET-400
ET-400 is a proprietary, patented formulation of liquid hydrocortisone developed by Eton Pharmaceuticals. It is designed to provide a convenient and accurate dosing option for patients requiring hydrocortisone therapy. If approved, ET-400 would be the only FDA-approved liquid formulation of hydrocortisone, offering a significant advantage over compounded formulations or off-label use of tablets.
