16 Jun 2025
💊FDA Determines Regulatory Review Period for VOYDEYA Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOYDEYA 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 content involves a determination of the regulatory review period which affects the extension of patent rights for VOYDEYA, a drug for treating paroxysmal nocturnal hemoglobinuria. This presents financial implications for companies in the pharmaceutical sector regarding patent protection and market exclusivity.