# 2025-11031: FDA Patent Review Notice Could Affect Generic Competition for VAFSEO

2025-11031, Determination of Regulatory Review Period for Purposes of Patent Extension; VAFSEO, 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 during the regulatory review period 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/2025-11031
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11031
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; VAFSEO
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25313
- 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 during the regulatory review period 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 Patent Review Notice Could Affect Generic Competition for VAFSEO

## Summary

The FDA has officially set the review period for the drug VAFSEO, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or wants to challenge the company’s effort during the review, they have until mid-2025 to speak up.

## Abstract

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

## Effects PRIA read

- FDA sets VAFSEO review period and extension request: cost, medium. FDA determined the regulatory review period for VAFSEO (vadadustat) is 5,336 days in total—4,241 days in the testing phase and 1,095 days in the approval phase. The applicant (Akebia Therapeutics, Inc.) seeks 1,094 days of patent term extension based on that period.
- Specific dates that define the review period: cost, low. FDA verified the investigational new drug (IND) effective date as August 19, 2009, the new drug application (NDA 215192) submission date as March 29, 2021, and the approval date as March 27, 2024. Those dates were used to calculate the 5,336-day regulatory review period.
- Opportunities to challenge dates or due diligence: benefit, low. Anyone who believes the published dates are incorrect may submit comments and request a redetermination by August 15, 2025. Any interested person may petition FDA to determine whether the applicant acted with due diligence during the regulatory review period by December 15, 2025.
- Patents named in the extension applications: cost, low. The USPTO received patent term restoration applications for VAFSEO for U.S. Patent Nos. 7,811,595; 8,323,671; 8,343,952; 8,598,210; and 8,940,773 from Akebia Therapeutics, Inc., and asked FDA to determine eligibility for restoration.

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## Sources
- [2025-11031 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11031/determination-of-regulatory-review-period-for-purposes-of-patent-extension-vafseo)
- [2025-11031 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11031.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-11031 (as of 2026-11-02).