# 2025-11040: FDA Sets Patent-Review Dates for Drugmaker's RIVFLOZA Extension Bid

2025-11040, Determination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Anyone may submit comments asking for a redetermination by August 15, 2025. Any interested person may petition FDA regarding the applicant's diligence during the regulatory review period by December 15, 2025.; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11040
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11040
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; RIVFLOZA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25305
- Published: 2025-06-16
- Effective: Anyone may submit comments asking for a redetermination by August 15, 2025. Any interested person may petition FDA regarding the applicant's diligence during the regulatory review period by December 15, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Sets Patent-Review Dates for Drugmaker's RIVFLOZA Extension Bid

## Summary

The FDA has officially set the review period for the drug RIVFLOZA, which helps the company extend its patent protection. This means the drug maker might get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. People can challenge the dates or the company’s diligence by mid-December 2025, so keep an eye on those deadlines!

## Abstract

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

## Effects PRIA read

- RIVFLOZA patent-extension potential: cost, high. FDA set RIVFLOZA's regulatory review period at 2,013 days (1,648 days testing phase and 365 days approval phase). The drugmaker (Novo Nordisk) has applied for 722 days of patent term extension, which could give the company extra time to keep RIVFLOZA exclusive and potentially delay when generic ver…
- Deadlines to challenge dates or diligence: benefit, low. If you think the dates are wrong, you may submit comments asking FDA for a redetermination by August 15, 2025. If you want FDA to decide whether the applicant acted with due diligence during the regulatory review period, you may file a petition by December 15, 2025, following the rules in 21 CFR 60…

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## Sources
- [2025-11040 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11040/determination-of-regulatory-review-period-for-purposes-of-patent-extension-rivfloza)
- [2025-11040 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11040.pdf)

## Related
- [Previous: 2025-11039, Determination of Regulatory Review Period for Purposes of Patent Extension; VOW…](https://policyrisk.com/federal-register/2025-11039)
- [Next: 2025-11041, Determination of Regulatory Review Period for Purposes of Patent Extension; ROL…](https://policyrisk.com/federal-register/2025-11041)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11040 (as of 2026-11-02).