# 2025-13044: KISUNLA Gets FDA Nod for Patent Extension Timeline

2025-13044, Determination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-07-14 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-13044
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-13044
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; KISUNLA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 31210
- Published: 2025-07-14
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

KISUNLA Gets FDA Nod for Patent Extension Timeline

## Summary

The FDA has officially set the review period for KISUNLA, a human biological product, so its patent can be extended. This helps the company get more time to protect their invention before others can copy it. If you’re involved in drug development or patents, this means important deadlines and opportunities are coming up.

## Abstract

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

- FDA OKs Patent Extension Window: benefit, medium. If you own or work for the company that makes KISUNLA (a human biological product), the FDA has set the regulatory review period so the company can apply to the U.S. Patent and Trademark Office to extend a patent that claims this product. This action makes a patent-extension opportunity official an…

## 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
- [2025-13044 on federalregister.gov](https://www.federalregister.gov/documents/2025/07/14/2025-13044/determination-of-regulatory-review-period-for-purposes-of-patent-extension-kisunla)
- [2025-13044 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-07-14/pdf/2025-13044.pdf)

## Related
- [Previous: 2025-13043, Determination of Regulatory Review Period for Purposes of Patent Extension; IMD…](https://policyrisk.com/federal-register/2025-13043)
- [Next: 2025-13045, Silver Point Specialty Credit Fund Management, LLC, et al.](https://policyrisk.com/federal-register/2025-13045)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-13044 (as of 2026-06-08).