# 2025-08450: FDA Sets EPKINLY Review Dates for a Possible Patent Extension

2025-08450, Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY, 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/2025-08450
- As of: 2026-10-20
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-08450
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 20474
- 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 Sets EPKINLY Review Dates for a Possible Patent Extension

## Summary

The FDA has officially set the review period for EPKINLY, a human biological product, which helps the company extend its patent protection. If anyone thinks the dates are wrong, they have until July 14, 2025, to speak up. Also, people can challenge whether the company acted quickly enough during the review by November 10, 2025. This affects patent holders and could impact how long they keep exclusive rights to their product.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.

## Effects PRIA read

- FDA Sets Patent-Extension Period for EPKINLY: benefit, medium. The FDA has determined the regulatory review period for EPKINLY, a human biological product, so the drugmaker can seek a patent-term extension. This lets the company get extra time to protect its invention and changes when and how long patent protections last.
- May Affect Market Timing and Financial Outcomes: mixed, low. The notice affects drug developers and patent stakeholders by changing the timing and duration of patent protections for EPKINLY, which can influence money and market timing for related products. Those involved in drug development or patenting may see effects on revenue timing and competitive entry.

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## Sources
- [2025-08450 on federalregister.gov](https://www.federalregister.gov/documents/2025/05/14/2025-08450/determination-of-regulatory-review-period-for-purposes-of-patent-extension-epkinly)
- [2025-08450 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-05-14/pdf/2025-08450.pdf)

## Related
- [Previous: 2025-08449, Determination of Regulatory Review Period for Purposes of Patent Extension; SKI…](https://policyrisk.com/federal-register/2025-08449)
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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-08450 (as of 2026-10-20).