💊FDA Determination of Regulatory Review Period for ZEVTERA Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEVTERA 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 regulation discusses the FDA’s determination of the regulatory review period for ZEVTERA, which has direct implications for patent term extensions. Businesses involved in the pharmaceutical industry should prepare for potential patent extensions and assess the competitive landscape. Companies can also engage in the comment and petition processes to influence determinations that may affect their market positioning and strategies.