💊FDA Notice on Patent Extension for EXEM FOAM
Determination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAM
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXEM FOAM 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
$$ - Med
The notice identifies the determination of a regulatory review period for patent extension of EXEM FOAM, which directly impacts revenue and market exclusivity for businesses involved in pharmaceuticals. It highlights compliance requirements and timelines for submitting petitions regarding patent extensions, making it crucial for stakeholders in the pharmaceutical industry.