14 Jul 2025
💊FDA Patent Extension Review for TECELRA and Business Implications
Determination of Regulatory Review Period for Purposes of Patent Extension; TECELRA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECELRA 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
$$$ - High
The regulatory determination for TECELRA's patent extension impacts business owners involved in pharmaceutical development and commercialization, as it outlines the potential for patent term restoration, directly affecting product market exclusivity and revenue potential.