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).
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2025-24269 — Determination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY
The FDA has officially set the review period for the drug BRENZAVVY, which helps the company apply for extra patent time. This affects the drug maker and anyone watching patent rules, giving a chance to challenge dates or the company’s effort by early 2026. It’s all about making sure the patent clock is fair and accurate, potentially impacting how long the drug stays exclusive on the market.
Next: 2025-24271 — Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results and Final Determination of No Shipments of Antidumping Duty Administrative Review; 2023-2024
The U.S. Department of Commerce confirmed that C&U Shanghai is grouped with all other Chinese companies for trade rules, while Shanghai Tainai didn’t ship any tapered roller bearings from June 2023 to May 2024. This means no special trade rates for C&U Shanghai and no duties for Tainai during this time. These decisions take effect starting January 5, 2026, impacting importers and manufacturers dealing with these bearings.
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in