🧪FDA Determines Patent Extension for ZUNVEYL Drug Product
Determination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYL
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZUNVEYL 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
This regulation impacts businesses involved in the pharmaceutical industry by establishing the patent extension process for ZUNVEYL. Business owners must comply with regulatory review periods and have the possibility to influence determinations through petitions or comments, potentially affecting their patent strategies and market entry timelines.