# 2025-23868: ZELSUVMI Drug Gets FDA Patent Extension Review Period

2025-23868, Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI, 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/2025-23868
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23868
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ZELSUVMI
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60700
- Published: 2025-12-29
- Effective: 2025-12-29
- Comments close: 2026-06-29
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

ZELSUVMI Drug Gets FDA Patent Extension Review Period

## Summary

The FDA has set the official review period for the drug ZELSUVMI, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. People can comment or challenge these dates by early 2026, so stay tuned if you have info to share!

## Abstract

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

## Effects PRIA read

- FDA Sets ZELSUVMI Review Period: cost, medium. You may see a delay in generic competition because the FDA determined the regulatory review period for ZELSUVMI is 4,144 days in total — 3,778 days in the testing phase and 366 days in the approval phase. Those dates (IND effective September 2, 2012; NDA submitted January 5, 2023; approved January…
- Company Seeks 1,280-Day Patent Extension: cost, medium. The patent applicant (LNHC, Inc.) is seeking 1,280 days of patent term extension for ZELSUVMI. Under law, a patent may be extended for up to 5 years, but the U.S. Patent and Trademark Office will apply statutory limits when calculating the actual extension.

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## Sources
- [2025-23868 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23868/determination-of-regulatory-review-period-for-purposes-of-patent-extension-zelsuvmi)
- [2025-23868 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23868.pdf)

## Related
- [Previous: 2025-23867, Determination of Regulatory Review Period for Purposes of Patent Extension; OJE…](https://policyrisk.com/federal-register/2025-23867)
- [Next: 2025-23869, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2025-23869)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-23868 (as of 2026-06-08).