FDA Sets Patent-Extension Clock for Drug With Unusual Name XOLREMDI
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the drug XOLREMDI, which helps the company extend its patent protection. This means the drug maker might get extra time to keep their invention exclusive, potentially affecting when generic versions can appear. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they have until late 2025 to speak up.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA sets XOLREMDI review period
FDA determined the regulatory review period for XOLREMDI is 6,923 days total: 6,683 days in the testing phase and 240 days in the approval phase. Key dates are: investigational new drug (IND) effective May 15, 2015; new drug application (NDA) initially submitted August 31, 2023; NDA approved April 26, 2024.
Company seeks ~490 days patent extension
X4 Pharmaceuticals has applied to the USPTO for patent term restoration and, in its applications, seeks either 490 days or 498 days of patent term extension for U.S. Patent Nos. 10,610,527; 10,953,003; and 11,219,621. FDA notes that its regulatory-review-period determination establishes the maximum potential length that the USPTO will use (subject to statutory limitations) when calculating any actual patent extension.
Deadlines to challenge dates or due diligence
Anyone who believes the published dates are incorrect can submit comments and request a redetermination by August 15, 2025. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, with filing instructions provided (electronic submissions at regulations.gov or written submissions to the Dockets Management Staff).
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Key Dates
Department and Agencies
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