2 Jul 2025
💊FDA Patent Extension Notice for WINREVAIR
Determination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIR
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINREVAIR 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 biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice discusses the regulatory review period for WINREVAIR and its patent extension implications. This directly impacts business owners in the pharmaceutical industry who may need to comply with the FDA's regulations and potential patent law changes, influencing market dynamics and product timelines.