# 2025-13048: HEMGENIX Patent Extension Period Set by FDA Regulators

2025-13048, Determination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX, 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/2025-13048
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-13048
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 31222
- 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

HEMGENIX Patent Extension Period Set by FDA Regulators

## Summary

The FDA has officially set the review period for HEMGENIX, a special medicine made from human biological material. This means the company can ask for extra time on their patent to protect their invention. If approved, this extension helps the makers keep their exclusive rights longer, which can impact when generic versions hit the market and affect money flow in the drug world.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HEMGENIX 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 Filing: benefit, medium. The FDA has determined the regulatory review period for HEMGENIX, a medicine made from human biological material. Because of that determination, the company can submit an application to the U.S. Patent and Trademark Office (USPTO) to ask for extra time on a patent that claims HEMGENIX.
- Possible Delay of Generic Competition: cost, medium. If the USPTO approves a patent extension for HEMGENIX, the maker could keep exclusive rights longer. You may pay higher prices or wait longer for lower-cost generic versions because this extension can affect when generics enter the market and the flow of money in the drug market.

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## Sources
- [2025-13048 on federalregister.gov](https://www.federalregister.gov/documents/2025/07/14/2025-13048/determination-of-regulatory-review-period-for-purposes-of-patent-extension-hemgenix)
- [2025-13048 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-07-14/pdf/2025-13048.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-13048 (as of 2026-06-08).