💊FDA Notice on Patent Extension for IQIRVO Drug Review Period
Determination of Regulatory Review Period for Purposes of Patent Extension; IQIRVO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IQIRVO 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 drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice pertains to the regulatory review period determination and the associated patent extension, which impacts pharmaceutical companies regarding IP rights, potential revenue, and competitive advantages. Businesses should be aware of timelines for petitions and public comments, as they may affect strategic decisions and compliance.