19 May 2025
💊FDA Notice on Regulatory Review Period for ELAHERE Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; ELAHERE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELAHERE 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
$$ - Med
The regulatory notice outlines the determination of the regulatory review period for patent extensions for the biologic product ELAHERE. This affects financial planning for businesses involved in drug development, as it signifies potential patent term extensions that can impact market exclusivity and revenue generation.