💊FDA Notice on BRIUMVI Patent Extension Implications
Determination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIUMVI 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 notice discusses the regulatory review period for BRIUMVI, which affects patent extensions. This could have financial implications for businesses involved in drug development, as patent extensions can influence market exclusivity and profitability. Additionally, potential petitions can impact regulatory strategies for stakeholders.