# 2025-11043: FDA Sets Patent-Extension Clock for an Infant Virus Prevention Product

2025-11043, Determination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Anyone with knowledge that any of the dates as published must submit comments and ask for a redetermination by August 15, 2025; petitions regarding whether the applicant acted with due diligence must be filed by December 15, 2025. (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11043
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11043
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25331
- Published: 2025-06-16
- Effective: Anyone with knowledge that any of the dates as published must submit comments and ask for a redetermination by August 15, 2025; petitions regarding whether the applicant acted with due diligence must be filed by December 15, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Sets Patent-Extension Clock for an Infant Virus Prevention Product

## Summary

The FDA has officially set the review period for BEYFORTUS, a human biological product, so its patent holder can apply for extra patent time. This helps the company protect their invention longer, encouraging innovation. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, they must act by mid or late 2025.

## Abstract

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

- FDA Sets BEYFORTUS Review Period: benefit, high. The FDA determined the regulatory review period for BEYFORTUS is 3,387 days in total, with 3,092 days in the testing phase and 295 days in the approval phase. The agency verified the key dates used: investigational exemption effective April 10, 2014; biologics license application (BLA B761328) subm…
- Applicant Seeks Specific Extension Lengths: benefit, medium. In its applications to the U.S. Patent and Trademark Office, the patent applicant seeks patent-term extensions of 49 days, 445 days, or 708 days for BEYFORTUS. The USPTO will apply statutory limitations when calculating the actual extension awarded.

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [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

## Sources
- [2025-11043 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11043/determination-of-regulatory-review-period-for-purposes-of-patent-extension-beyfortus)
- [2025-11043 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11043.pdf)

## Related
- [Previous: 2025-11042, Submission for OMB Review; Comment Request; Reinstatement](https://policyrisk.com/federal-register/2025-11042)
- [Next: 2025-11044, Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting](https://policyrisk.com/federal-register/2025-11044)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11043 (as of 2026-11-02).