14 Jul 2025
💊FDA Notice on Regulatory Review Period for ABRYSVO Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABRYSVO 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 notice discusses the regulatory review period for ABRYSVO, which impacts patent extension efforts. Businesses in the pharmaceutical industry must ensure compliance with FDA regulations and may benefit from extended patent protection for products, thus influencing financial strategies and market positioning.