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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20063, Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The FDA is looking for smart, qualified people to join its advisory committees and help make important decisions about food and drugs. If you have the right skills, you can apply anytime, but get your nomination in by November 30, 2026, for the best chance at current openings. This is a great chance to influence public health without any cost to you!
Previous / Next Documents
Previous: 2026-02971, Determination of Regulatory Review Period for Purposes of Patent Extension; ATTRUBY
The FDA has set the official review period for ATTRUBY, a human drug, so its patent holder can apply for extra patent time. This affects the drug company by potentially extending their exclusive rights, giving them more time to make money before generics arrive. People can challenge the dates or the company’s effort by mid-2026, so keep an eye on those deadlines!
Next: 2026-02973, Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY
The FDA has officially set the review period for CRENESSITY, a new drug, so its patent can be extended. This helps the drug maker get extra time to protect their invention, which could affect when generic versions hit the market. If anyone thinks the dates are wrong or wants to challenge the drug maker’s speed during review, they have until April 14 or August 12, 2026, to speak up.