2026-06479Notice

FDA Clocks Review Time for ENFLONSIA Patent Extension Bid

Published Date: 4/3/2026

Notice

Summary

The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent extensions or drug approvals. If you think the dates are wrong or want to challenge the patent holder’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market timing.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
Comments Due
4/3/2026
6/2/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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