14 Jul 2025
💊FDA Announces Regulatory Review Period for IMDELLTRA Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMDELLTRA 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 outlines regulatory determinations relevant to patent extensions for the human biological product IMDELLTRA, impacting businesses in the pharmaceutical sector. Compliance with new review periods and potential petitions is crucial for patent holders seeking extended protections.