# 2025-08462: FDA Patent Clock Gets Official Dates for Drug Called Adbry

2025-08462, Determination of Regulatory Review Period for Purposes of Patent Extension; ADBRY, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-05-14 (as of 2026-10-20).

- Canonical: https://policyrisk.com/federal-register/2025-08462
- As of: 2026-10-20
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-08462
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ADBRY
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 20469
- Published: 2025-05-14
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-10-20

## In one line

FDA Patent Clock Gets Official Dates for Drug Called Adbry

## Summary

The FDA has set the official review period for ADBRY, a human biological product, so its patent holder can apply for extra patent time. If you think the dates are wrong, you have until July 14, 2025, to speak up. Also, anyone can challenge whether the company was diligent during the review by November 10, 2025. This affects the patent timeline and could impact how long the product stays protected.

## Abstract

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

No economic effects identified for this document.

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## Sources
- [2025-08462 on federalregister.gov](https://www.federalregister.gov/documents/2025/05/14/2025-08462/determination-of-regulatory-review-period-for-purposes-of-patent-extension-adbry)
- [2025-08462 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-05-14/pdf/2025-08462.pdf)

## Related
- [Previous: 2025-08460, Meeting of Humanities Panel](https://policyrisk.com/federal-register/2025-08460)
- [Next: 2025-08463, Notice of Public Meeting of the New Mexico Advisory Committee to the U.S. Commi…](https://policyrisk.com/federal-register/2025-08463)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-08462 (as of 2026-10-20).