16 Jun 2025
💊FDA Notice on Regulatory Review Period for XOLREMDI Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; XOLREMDI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOLREMDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
This document outlines the FDA's determination regarding the regulatory review period for XOLREMDI, which impacts patent extensions crucial for businesses in the pharmaceutical sector. Patent extensions can provide significant financial benefits and competitive advantages to businesses holding the patents.