← Back to FR Documents
Notice

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

Notice.

📖 Research Context From Federal Register API

Summary:

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LEQEMBI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.

Key Dates
Citation: 90 FR 60717
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by February 27, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 29, 2026. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
Comments close: February 27, 2026
Public Participation

Document Details

Document Number2025-23865
FR Citation90 FR 60717
TypeNotice
PublishedDec 29, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2023-E-3236
Pages60717–60719 (3 pages)
Text FetchedNo

Agencies & CFR References

Agency Hierarchy:
Health and Human Services Department→Food and Drug Administration
CFR References:
None

Linked CFR Parts

PartNameAgency
No linked CFR parts

Paired Documents

TypeProposedFinalMethodConf
No paired documents

External Links

View on FederalRegister.gov Search Regulations.gov

Full Text

Text Not Yet Fetched

The full text for this document hasn't been fetched yet. The system will automatically retrieve it during the next processing cycle.