25 Jun 2025
💊FDA Notice on Regulatory Review Period for FILSPARI Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; FILSPARI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSPARI 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 drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory notice discusses the determination of the review period for FILSPARI, which affects patent extension applications. Business implications stem from compliance requirements surrounding patent reviews that can impact pharmaceutical companies’ market exclusivity and financial returns.