# 2025-23863: FDA Sets Patent Review Period for ALHEMO Biological Product

2025-23863, Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective Anyone may ask for a redetermination by February 27, 2026; petitions regarding whether the applicant acted with due diligence must be filed by June 29, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23863
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23863
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60729
- Published: 2025-12-29
- Effective: Anyone may ask for a redetermination by February 27, 2026; petitions regarding whether the applicant acted with due diligence must be filed by June 29, 2026.
- Comments close: 2026-02-27
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Sets Patent Review Period for ALHEMO Biological Product

## Summary

The FDA has officially set the review period for ALHEMO, a human biological product, which helps the company extend its patent protection. This means the patent clock can be paused, giving the maker more time to benefit from their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they have until early 2026 to speak up.

## Abstract

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

## Related documents

- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27
- [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09

## Sources
- [2025-23863 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23863/determination-of-regulatory-review-period-for-purposes-of-patent-extension-alhemo)
- [2025-23863 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23863.pdf)

## Related
- [Previous: 2025-23862, Determination of Regulatory Review Period for Purposes of Patent Extension; ROM…](https://policyrisk.com/federal-register/2025-23862)
- [Next: 2025-23864, Determination of Regulatory Review Period for Purposes of Patent Extension; ADZ…](https://policyrisk.com/federal-register/2025-23864)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-23863 (as of 2026-06-08).