# 2025-23867: FDA Clocks Patent Extension Time for OJEMDA Drug

2025-23867, Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA, 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/2025-23867
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23867
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60722
- Published: 2025-12-29
- Effective: 2025-12-29
- Comments close: 2026-02-27
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Clocks Patent Extension Time for OJEMDA Drug

## Summary

The FDA has set the official review period for the drug OJEMDA, which helps the company extend its patent and protect their invention longer. This affects the drug maker and anyone tracking patent dates, with deadlines to challenge or comment on these dates by early 2026. It’s a key step to keep innovation alive while making sure the patent system stays fair and on schedule.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OJEMDA 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 OJEMDA review period length: benefit, medium. FDA determined the regulatory review period for OJEMDA (tovorafenib) is 4,942 days total: 4,705 days in the testing phase and 237 days in the approval phase. FDA lists the key dates used: IND effective October 14, 2010; NDA initially submitted August 31, 2023 (NDA 217700); and approval on April 23,…
- Deadlines to challenge or petition dates: mixed, low. Anyone who believes the published dates are wrong may submit comments and request a redetermination by February 27, 2026. Any interested person may petition FDA about whether the applicants acted with due diligence during the regulatory review period by June 29, 2026.
- Applicants seek 5-year patent extension: mixed, medium. The applicants (Day One Biopharmaceuticals, Inc. and Viracta Therapeutics, Inc.) seek 5 years of patent-term extension for U.S. Patent No. 8,293,752. FDA notes this determination establishes the maximum potential length, but the USPTO will apply statutory limitations when calculating the actual ext…

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## Sources
- [2025-23867 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23867/determination-of-regulatory-review-period-for-purposes-of-patent-extension-ojemda)
- [2025-23867 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23867.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-23867 (as of 2026-06-08).