26 Aug 2025
💊FDA Announces Regulatory Review Period for YORVIPATH Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; YORVIPATH
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YORVIPATH 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 claim that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The determination of the regulatory review period for YORVIPATH by the FDA directly impacts businesses looking for patent extensions, affecting their financial and compliance strategies. This includes timelines for submissions, which can have significant implications for operational planning and market timing.