FDA Clocks Review Time for AUGTYRO: Patent Perks Incoming
Published Date: 1/5/2026
Notice
Summary
The FDA has officially set the review period for AUGTYRO, a human drug, so its patent holder can apply for extra patent time. This affects the drug company and anyone tracking patent extensions, with deadlines to challenge dates or diligence claims by March 6 and July 6, 2026. It’s a key step to keep innovation protected while making sure the process stays fair and on schedule.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
AUGTYRO Regulatory Review Period Set
FDA determined the regulatory review period for the human drug AUGTYRO (repotrectinib) is 2,574 days total: 2,340 days in the testing phase and 234 days in the approval phase. FDA identifies the IND effective date as October 30, 2016, the NDA submission date as March 27, 2023, and the approval date as November 15, 2023. The patent applicant (U.S. Patent No. 9,714,258, Turning Point Therapeutics, Inc.) seeks 1,027 days of patent term extension.
Deadlines To Challenge Dates or Diligence
Anyone with knowledge that the published dates are incorrect may request a redetermination by March 6, 2026. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by July 6, 2026; petitions must follow 21 CFR 60.30 and be submitted electronically at https://www.regulations.gov (or as written submissions to the FDA Dockets Management address).
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Key Dates
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