# 2025-11038: FDA Sets ZEVTERA Review Dates in Routine Patent-Extension Notice

2025-11038, Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective 2025-06-11; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11038
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11038
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25316
- Published: 2025-06-16
- Effective: 2025-06-11
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Sets ZEVTERA Review Dates in Routine Patent-Extension Notice

## Summary

The FDA has officially set the review period for the drug ZEVTERA, which helps the company extend its patent protection. This means the drug maker could get extra time to keep exclusive rights, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, 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 ZEVTERA 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

- FDA sets ZEVTERA review period and extension request: benefit, high. FDA determined the regulatory review period for ZEVTERA is 7,790 days total, with 7,545 days in the testing phase and 245 days in the approval phase. FDA records show the IND effective date as December 7, 2002, the NDA was submitted on August 3, 2023, and approval occurred on April 3, 2024; the pat…
- Public deadlines to challenge dates and diligence: benefit, low. Anyone may submit comments asking FDA to redetermine the published dates by August 15, 2025, and any interested person may petition FDA about whether the applicant acted with due diligence by December 15, 2025. Comments may be submitted electronically at https://www.regulations.gov (see Docket No.…

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## Sources
- [2025-11038 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11038/determination-of-regulatory-review-period-for-purposes-of-patent-extension-zevtera)
- [2025-11038 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11038.pdf)

## Related
- [Previous: 2025-11034, Determination of Regulatory Review Period for Purposes of Patent Extension; NA…](https://policyrisk.com/federal-register/2025-11034)
- [Next: 2025-11039, Determination of Regulatory Review Period for Purposes of Patent Extension; VOW…](https://policyrisk.com/federal-register/2025-11039)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11038 (as of 2026-11-02).