26 Aug 2025
💊FDA Regulatory Review Period Determination for VORANIGO
Determination of Regulatory Review Period for Purposes of Patent Extension; VORANIGO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VORANIGO 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 document discusses the FDA's determination of the regulatory review period for VORANIGO, which affects patent eligibility for pharmaceutical companies. It outlines compliance requirements for businesses seeking patent extensions and the potential for financial implications from extended market exclusivity.