FDA Clocks Patent Extension Time for OJEMDA Drug
Published Date: 12/29/2025
Notice
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.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
FDA sets OJEMDA review period length
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, 2024.
Applicants seek 5-year patent extension
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 extension.
Deadlines to challenge or petition dates
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.
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