14 Jul 2025
💊FDA Notice on Patent Extension for KISUNLA Regulatory Review
Determination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISUNLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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
$$ - Med
The document addresses regulatory review periods for patent extensions, specifically for KISUNLA, a biologic product for Alzheimer's. The determination can lead to financial implications for businesses holding or pursuing patents, impacting market exclusivity and competitive advantage.