29 Sep 2025
💊FDA Notice on NIKTIMVO Patent Extension Review Period
Determination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NIKTIMVO 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 biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text discusses patent extensions for the biologic product NIKTIMVO, which directly affects businesses in the pharmaceutical and biotechnology sectors. The potential for patent extension could impact market exclusivity and revenues for stakeholders involved.