💉FDA Notice on SKINVIVE Patent Extension Regulatory Review
Determination of Regulatory Review Period for Purposes of Patent Extension; SKINVIVE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKINVIVE 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 medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory determination regarding the patent extension for SKINVIVE has direct financial implications for businesses in the medical device sector, specifically relating to the commercialization timeline and potential market exclusivity resulting from a patent extension. Companies should be aware of the regulations and petition processes involved.