2026-01587Notice

Determination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP

Published Date: 1/27/2026

Notice

Summary

The FDA has officially set the review period for EXBLIFEP, a human drug, so its patent holder can apply for extra patent time. This affects the drug company and anyone tracking patent extensions, with deadlines to challenge dates or diligence claims by March 30 and July 27, 2026. It’s a key step to keep innovation protected while making sure the process stays fair and on schedule.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
Comments Due
1/27/2026
3/30/2026

Department and Agencies

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