💊FDA's Regulatory Review Notice for NEMLUVIO Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEMLUVIO 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 text discusses the FDA's determination of the regulatory review period for NEMLUVIO, impacting patent extension applications crucial for pharmaceutical companies. This influences how long businesses can protect their intellectual property, directly affecting product launch strategies and financial planning in pharmaceuticals.