# 2025-13043: FDA Clocks In Extra Time for IMDELLTRA Patent Protection

2025-13043, Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA, 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/2025-13043
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-13043
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; IMDELLTRA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 31215
- 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

FDA Clocks In Extra Time for IMDELLTRA Patent Protection

## Summary

The FDA has officially set the review period for IMDELLTRA, a human biological product, so its patent can be extended. This helps the company get extra time to protect their invention before generic versions can appear. If you’re in the business of making or selling this product, this timing update is key for planning and profits.

## Abstract

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

- Patent Extension Window for IMDELLTRA: benefit, medium. If you make or sell IMDELLTRA, the FDA has set the product's regulatory review period so the company can apply to extend a patent that claims this human biological product. That extension gives the company extra time to protect the product before generic versions can appear, which matters for busin…

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## Sources
- [2025-13043 on federalregister.gov](https://www.federalregister.gov/documents/2025/07/14/2025-13043/determination-of-regulatory-review-period-for-purposes-of-patent-extension-imdelltra)
- [2025-13043 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-07-14/pdf/2025-13043.pdf)

## Related
- [Previous: 2025-13042, Agency Information Collection Activities: Proposed Collection; Comment Request](https://policyrisk.com/federal-register/2025-13042)
- [Next: 2025-13044, Determination of Regulatory Review Period for Purposes of Patent Extension; KIS…](https://policyrisk.com/federal-register/2025-13044)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-13043 (as of 2026-06-08).