# 2025-13046: ABRYSVO's Patent Review Period Locked In by FDA

2025-13046, Determination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO, 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/2025-13046
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-13046
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ABRYSVO
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 31224
- 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

ABRYSVO's Patent Review Period Locked In by FDA

## Summary

The FDA has officially set the review period for ABRYSVO, a new human biological product. This means the company can apply to extend its patent, giving them more time to protect their invention. If approved, this could affect when generic versions hit the market and impact future drug prices.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABRYSVO 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 Sets Review Period for ABRYSVO: benefit, medium. The FDA has determined the regulatory review period for ABRYSVO, a human biological product. The company submitted an application to the U.S. Patent and Trademark Office to extend a patent that claims ABRYSVO, allowing the company to seek additional time to protect its invention.
- Possible Delay of Generics and Price Effects: cost, medium. If the patent extension for ABRYSVO is approved, it could delay when generic versions reach the market and could affect future drug prices. This change would influence when patients and buyers can access lower-cost alternatives.

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## Sources
- [2025-13046 on federalregister.gov](https://www.federalregister.gov/documents/2025/07/14/2025-13046/determination-of-regulatory-review-period-for-purposes-of-patent-extension-abrysvo)
- [2025-13046 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-07-14/pdf/2025-13046.pdf)

## Related
- [Previous: 2025-13045, Silver Point Specialty Credit Fund Management, LLC, et al.](https://policyrisk.com/federal-register/2025-13045)
- [Next: 2025-13047, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2025-13047)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-13046 (as of 2026-06-08).