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Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
Comment period closed: closed 110 days ago (Jun 29, 2026).
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZELSUVMI 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.
- Document type
- Notice
- Federal Register document number
- 2025-23868
- Published
- Dec 29, 2025
- Action
- Notice.
- Docket
- FDA-2024-E-1293
- Comments posted on Regulations.gov (at last check)
- 1
- DATES section (from the document)
- 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 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.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2025-23868. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.