12 May 2025
💊FDA Notice on SUNLENCA Regulatory Review Period and Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; SUNLENCA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SUNLENCA 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
$$$ - High
The regulation determines the length of the regulatory review period for SUNLENCA, which may significantly impact Gilead Sciences, Inc. by extending its patent and hence its market exclusivity. This influences business strategy, potential revenue, and competition within the pharmaceutical market.