20 Jun 2025
💊FDA Patent Extension Notice for COLUMVI
Determination of Regulatory Review Period for Purposes of Patent Extension; COLUMVI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COLUMVI 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
$$ - Med
The text discusses the FDA's determination of the regulatory review period for COLUMVI, which relates to the extension of patent protections for the drug. This can impact financial planning for businesses relying on associated patent rights and market entry strategies for similar products.