💊FDA Determines Regulatory Review Period for ELREXFIO Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO 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 document discusses the FDA's determination regarding the regulatory review period for the human biological product ELREXFIO, which is essential for Pfizer Inc. in seeking patent extensions. This has significant implications for patent strategy, market exclusivity, and financial forecasting for related businesses in the pharmaceutical industry.