2025-23863Notice

FDA Sets Patent Review Period for ALHEMO Biological Product

Published Date: 12/29/2025

Notice

Summary

The FDA has officially set the review period for ALHEMO, a human biological product, which helps the company extend its patent protection. This means the patent clock can be paused, giving the maker more time to benefit from their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they have until early 2026 to speak up.

No Economic Impacts Identified for this Document

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Key Dates

Published Date
Comments Due
12/29/2025
2/27/2026

Department and Agencies

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