FDA Clocks Review Time for RYTELO Drug Patent Boost
Published Date: 2/13/2026
Notice
Summary
The FDA has officially set the review period for the drug RYTELO, which helps the company apply for extra patent time to protect their invention. This affects the drug maker and anyone tracking patent extensions, with deadlines to challenge dates or diligence claims by April 14 and August 12, 2026. It’s a key step to keep innovation protected while making sure the process stays fair and on schedule.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA Sets RYTELO Review Period
FDA determined the regulatory review period for the drug RYTELO is 6,967 days in total. That includes 6,610 days in the testing phase and 357 days in the approval phase, and this determination establishes the maximum potential length of a patent extension.
Applicant Requests Specific Extension Durations
The patent applicant (Geron Corporation) has applied for patent term restoration and seeks extensions of 1,464 days, 1,622 days, 1,629 days, or the maximum 5 years for U.S. Patent Nos. 7,494,982; 9,375,485; 9,388,415; 9,388,416; and 9,657,296. The USPTO will apply statutory limitations when calculating the actual extension granted.
Deadlines To Challenge Dates or Diligence
Anyone who believes the published dates are incorrect may ask FDA for a redetermination by April 14, 2026. Any interested person may petition FDA about whether the patent applicant acted with due diligence during the regulatory review period by August 12, 2026, and such petitions must meet the requirements of 21 CFR 60.30.
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