AUCATZYL Patent Timeline Locked: Speak Up by April 2026
Published Date: 2/13/2026
Notice
Summary
The FDA has officially set the review period for AUCATZYL, a human biological product, which helps decide how long its patent can be extended. This affects the company behind AUCATZYL and anyone tracking patent timelines, with key deadlines for public comments and petitions coming up in April and August 2026. If you think the dates are wrong or want to challenge the applicant’s diligence, now’s the time to speak up!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA sets AUCATZYL review period
The FDA determined the regulatory review period for AUCATZYL is 1,671 days total — 1,313 days in the testing phase and 358 days in the approval phase. Those periods are tied to the dates April 14, 2020 (testing start), November 17, 2023 (BLA submission), and November 8, 2024 (approval).
Applicant seeks 496 or 705 days extension
In its patent-extension application, the applicant seeks either 496 days or 705 days of patent term extension, while FDA's determination establishes a maximum potential period; the USPTO will apply statutory limits when calculating the actual extension amount.
Deadlines to challenge dates and diligence
If you believe any published dates are wrong, you must ask for a redetermination by April 14, 2026. If you want FDA to decide whether the applicant acted with due diligence during the review period, you must file a petition by August 12, 2026.
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Key Dates
Department and Agencies
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