2 Jul 2025
💊FDA Determines Regulatory Review Period for LIVDELZI Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; LIVDELZI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LIVDELZI 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 patents which claim that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's determination of the regulatory review period for LIVDELZI has implications for patent extension which affects market exclusivity and financial forecasting for Gilead Sciences and associated investors. The ability to extend patents influences revenue projections directly tied to the drug's sales potential.