# 2025-11024: BRIUMVI Gets an FDA Review Timeline for Patent Extension

2025-11024, Determination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVI, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Comments challenging any published dates must be submitted by August 15, 2025. Petitions challenging whether the applicant acted with due diligence must be submitted by December 15, 2025.; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11024
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11024
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; BRIUMVI
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25336
- Published: 2025-06-16
- Effective: Comments challenging any published dates must be submitted by August 15, 2025. Petitions challenging whether the applicant acted with due diligence must be submitted 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

BRIUMVI Gets an FDA Review Timeline for Patent Extension

## Summary

The FDA has set the official review period for BRIUMVI, a new medicine, so its patent can be extended. This helps the company behind BRIUMVI get extra time to protect their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during the review, they must speak up by August 15 or December 15, 2025.

## Abstract

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

## Effects PRIA read

- FDA sets 3,920-day review period for BRIUMVI: benefit, high. The FDA determined BRIUMVI’s regulatory review period is 3,920 days total, made up of a 3,463-day testing phase and a 457-day approval phase. FDA verified the key dates used: the investigational new drug effective date of April 6, 2012; biologics license application (BLA 761238) submission on Septe…
- Deadlines to challenge dates and applicant diligence: benefit, low. Anyone who believes the published dates are incorrect may submit comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the patent applicant acted with due diligence during the regulatory review period by December 15, 2025, following the proc…

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## Sources
- [2025-11024 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11024/determination-of-regulatory-review-period-for-purposes-of-patent-extension-briumvi)
- [2025-11024 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11024.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11024 (as of 2026-11-02).