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Notice

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

Notice.

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Summary:

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

Key Dates
Citation: 90 FR 57202
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 Number2025-22382
FR Citation90 FR 57202
TypeNotice
PublishedDec 10, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2025-E-0861
Pages57202–57203 (2 pages)
Text FetchedNo

Agencies & CFR References

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

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