20 Jun 2025
💊FDA Determines Regulatory Review Period for ZILBRYSQ Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; ZILBRYSQ
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZILBRYSQ 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 a patent which claims that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document details a determination by the FDA regarding the regulatory review period for the drug ZILBRYSQ, which directly affects patent extension rights. This has financial implications for businesses involved in pharmaceuticals, as patent extensions may influence market exclusivity and pricing strategies.