# 2025-11041: FDA Sets Patent Review Period for Drug ROLVEDON

2025-11041, Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Comments and requests for redetermination must be submitted by August 15, 2025. Petitions regarding 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/2025-11041
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11041
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25328
- Published: 2025-06-16
- Effective: Comments and requests for redetermination must be submitted by August 15, 2025. Petitions regarding 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

FDA Sets Patent Review Period for Drug ROLVEDON

## Summary

The FDA has officially set the review period for ROLVEDON, a new medicine, so its patent can be extended. This helps the company protect their invention longer, giving them more time to make money before generics show up. If anyone thinks the dates are wrong or wants to challenge the company’s effort during 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 ROLVEDON 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 biological product.

## Effects PRIA read

- FDA sets ROLVEDON review period and dates: benefit, high. FDA determined the regulatory review period for ROLVEDON is 4,720 days in total — 3,668 days in the testing phase and 1,052 days in the approval phase. FDA cites the investigational new drug (IND) effective date as October 9, 2009; the biologics license application (BLA) submission date as October…
- Deadlines to challenge dates or applicant diligence: benefit, low. Anyone who knows any of the published dates are incorrect can submit comments and ask for a redetermination by August 15, 2025 (submit electronically at https://www.regulations.gov). Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory re…

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## Sources
- [2025-11041 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11041/determination-of-regulatory-review-period-for-purposes-of-patent-extension-rolvedon)
- [2025-11041 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11041.pdf)

## Related
- [Previous: 2025-11040, Determination of Regulatory Review Period for Purposes of Patent Extension; RIV…](https://policyrisk.com/federal-register/2025-11040)
- [Next: 2025-11042, Submission for OMB Review; Comment Request; Reinstatement](https://policyrisk.com/federal-register/2025-11042)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11041 (as of 2026-11-02).