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Notice

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

Notice.

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Summary:

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSUVEZ 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 drug product.

Key Dates
Citation: 90 FR 57200
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by February 9, 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 8, 2026. See "Petitions" in the SUPPLEMENTARY INFORMATION section for more information.
Comments close: February 9, 2026
Public Participation

Document Details

Document Number2025-22380
FR Citation90 FR 57200
TypeNotice
PublishedDec 10, 2025
Effective Date-
RIN-
Docket IDDocket Nos. FDA-2024-E-1290
Pages57200–57202 (3 pages)
Text FetchedNo

Agencies & CFR References

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

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