# 2025-23864: FDA Grants Extra Patent Time for ADZYNMA Drug Review

2025-23864, Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective 2025-12-29 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23864
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23864
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60727
- Published: 2025-12-29
- Effective: 2025-12-29
- Comments close: 2026-02-27
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Grants Extra Patent Time for ADZYNMA Drug Review

## Summary

The FDA has set the official review period for ADZYNMA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ADZYNMA and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until early 2026 to speak up—so keep an eye on those deadlines!

## Abstract

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

- Regulatory Review Period Set at 4,059 Days: benefit, medium. FDA determined that ADZYNMA's regulatory review period is 4,059 days total, consisting of 3,821 days in the testing phase and 238 days in the approval phase. This determination (using IND effective date September 30, 2012; BLA submission March 17, 2023; approval November 9, 2023) establishes the ma…
- Applicants Seek Specific Extension Lengths: benefit, high. The patent applicants for ADZYNMA have applied to the USPTO seeking patent term extensions of 702 days, 1,346 days, 1,479 days, 1,916 days, or the statutory maximum of 5 years. The USPTO will apply statutory limitations in calculating the actual extension that may be granted.

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## Sources
- [2025-23864 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23864/determination-of-regulatory-review-period-for-purposes-of-patent-extension-adzynma)
- [2025-23864 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23864.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-23864 (as of 2026-06-08).