20 Jun 2025
💊FDA Notice on JOENJA Regulatory Review and Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; JOENJA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JOENJA 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 notice discusses the regulatory review period for JOENJA, relevant to patent extension, which directly affects business operations in the pharmaceuticals sector. Companies interested in patent protections and extensions must comply with FDA and USPTO regulations, impacting their financial strategies and market positioning.