💊FDA Announces Regulatory Review Determination for OHTUVAYRE
Determination of Regulatory Review Period for Purposes of Patent Extension; OHTUVAYRE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OHTUVAYRE 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 patents which claim that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The content outlines the FDA's determination of the regulatory review period for the human drug OHTUVAYRE, impacting patent extensions. This affects business owners and executives in the pharmaceutical sector regarding potential patent protections and market exclusivity, relevant for strategic planning and financial forecasting.