💊FDA Notice on Patent Extension for REBYOTA Drug
Determination of Regulatory Review Period for Purposes of Patent Extension; REBYOTA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBYOTA 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 biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document involves regulatory requirements related to patent extensions for a human biological product, REBYOTA, which affects businesses in the biopharmaceutical sector. Companies must ensure compliance with these regulations and can consider petitioning for determinations affecting their patent timelines and market strategies.