20 Jun 2025
💊FDA Notice on BREYANZI Regulatory Review Period and Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; BREYANZI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BREYANZI 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 document details a determination of the regulatory review period for the drug BREYANZI, affecting patent extension eligibility and potentially impacting revenue for Juno Therapeutics and its partners. Businesses need to be aware of compliance and the timelines for filing petitions regarding patent extensions.