12 May 2025
💊FDA Notice on NGENLA Regulatory Review Period and Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NGENLA 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 content involves a determination by the FDA regarding the regulatory review period for NGENLA, impacting potential patent extensions crucial for pharmaceutical firms. This regulation affects business strategy, R&D investment decisions, and market exclusivity.