16 Jun 2025
🏥FDA Patent Extension Notification for Navitor Valve
Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT 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 medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation directly impacts businesses involved in the medical device industry, particularly those seeking patent extensions. It highlights regulatory review periods and potential patent term restorations, which can significantly influence market dynamics and competitive positioning.