AMTAGVI Gets FDA Patent Boost: Challenge by August 2026
Published Date: 2/13/2026
Notice
Summary
The FDA has officially set the review period for AMTAGVI, a new human biological product, so its patent can be extended. This affects the company behind AMTAGVI and anyone interested in patent timing or drug availability. If you think the dates are wrong or want to challenge the company’s diligence, you have until April 14 or August 12, 2026, to speak up—so don’t miss these deadlines!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
AMTAGVI Review Period Set
The FDA determined AMTAGVI's regulatory review period is 3,306 days in total: 2,969 days in the testing phase and 337 days in the approval phase. FDA verified the testing phase began on January 30, 2015, the biologics license application was submitted on March 17, 2023, and the application was approved on February 16, 2024. This determination establishes the maximum potential length of a patent extension; the applicant is seeking 42 days of patent term extension and the USPTO will apply statutory limits when calculating the actual extension.
Deadlines To Challenge Dates
Anyone who believes the published dates are incorrect may submit comments and ask 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 petitions must meet the requirements of 21 CFR 60.30 and related filing rules.
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