💊FDA Notice on ALTUVIIIO Patent Extension and Review Period
Determination of Regulatory Review Period for Purposes of Patent Extension; ALTUVIIIO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALTUVIIIO 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 outlines the regulatory review period for ALTUVIIIO, which may result in patent extensions impacting the financial landscape for the manufacturer, Bioverativ Therapeutics Inc. Compliance factors such as timely submission of comments and petitions for patent determination also directly affect business practices and regulatory compliance costs.