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Notice

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

Notice.

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Summary:

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OJEMDA 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 60722
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 27, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicants 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 Number2025-23867
FR Citation90 FR 60722
TypeNotice
PublishedDec 29, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2024-E-3865
Pages60722–60724 (3 pages)
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Agencies & CFR References

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

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