💊FDA Notice on Regulatory Review Period Determination for LOQTORZI
Determination of Regulatory Review Period for Purposes of Patent Extension; LOQTORZI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LOQTORZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 FDA's determination of the regulatory review period for LOQTORZI, which directly impacts patent extension for businesses involved in biopharmaceuticals. This affects market exclusivity and financial projections for companies holding relevant patents. Patent term extensions can influence pricing strategies and investment planning.