💊FDA Announces Regulatory Review Period and Patent Extension for AGAMREE
Determination of Regulatory Review Period for Purposes of Patent Extension; AGAMREE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGAMREE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 regulatory notice focuses on the determination of the regulatory review period for AGAMREE, which impacts patent extension determinations. This is significant for pharmaceutical companies as it relates to market exclusivity and potential financial benefits from extended patent protection. Companies may need to adjust strategies based on regulatory timelines and potential patent extensions.