💊FDA Determination on EPKINLY Patent Extension and Regulatory Review
Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulation involves patent extension determinations, which are critical for businesses in the pharmaceuticals and biotechnology sectors. The analysis of EPKINLY's regulatory review period and the associated patent extension opportunity can significantly affect market strategies, financial planning, and product lifecycle management for proprietary drugs.