FDA Clocks Extra Patent Time for BRENZAVVY Drug
Published Date: 1/5/2026
Notice
Summary
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.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
FDA sets BRENZAVVY review period
The FDA determined the regulatory review period for the drug BRENZAVVY is 5,098 days in total — 4,642 days in the testing phase and 456 days in the approval phase. FDA lists the key dates as: IND effective February 6, 2009; NDA submitted October 22, 2021; NDA approved January 20, 2023. This determination establishes the maximum potential length of any patent term extension for this product.
Applicant’s claimed extension days listed
In its patent extension applications related to BRENZAVVY (four listed U.S. patents), the applicant seeks specific extension lengths of 548, 779, 1,769, or 1,826 days. The notice also notes that the USPTO will apply statutory limitations when calculating the actual extension granted.
Window to challenge dates and diligence
Anyone who believes the published dates are incorrect may request a redetermination by March 6, 2026, and any interested person may petition FDA to review whether the applicant acted with due diligence during the regulatory review period by July 6, 2026. Comments and petitions must follow the submission instructions in the notice (electronic or written).
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
2026-11739 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
The FDA is officially putting simple COVID-19 rapid test devices into a safer, easier-to-manage category called Class II. This change means these tests can get to patients faster and with fewer hoops to jump through, while still making sure they work well and stay safe. Starting June 11, 2026, companies making these tests will follow new rules that help speed up innovation without extra costs.
2026-11740 — Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
The FDA is officially putting the Spinal Muscular Atrophy (SMA) newborn screening test into class II, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps make the test safer and easier to get to babies who need it, starting June 11, 2026, with the classification effective since November 2022. Labs and device makers will benefit from clearer rules and faster access, helping catch SMA early without extra costs or delays.
2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
The FDA is asking for approval to collect extra records from food businesses that handle certain high-risk foods. This helps track food sources quickly to keep everyone safe. Food companies should get ready to keep and share these new records, and comments on this plan are due by July 13, 2026.
2026-11762 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA is asking for approval to keep collecting info from seafood processors and importers to make sure fish products are safe using a system called HACCP. This affects anyone who processes or imports fish and requires them to keep records showing they’re following safety rules. Comments on this plan are open until July 13, 2026, and there’s no new cost, just a continuation of current paperwork.
2026-11589 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
The FDA has officially placed the combined acoustic and electrical external stimulation device for tinnitus relief into class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to this innovative device faster and ensures it’s safe and effective. The new classification is effective June 10, 2026, with the rules applying retroactively from March 6, 2023.
2026-11578 — Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
The FDA just gave a thumbs-up to adding bemotrizinol as a new active ingredient in sunscreens, letting it be used up to 6% concentration. This means sunscreen makers can now include this ingredient, which is safe and effective, in their products. The change is official as of June 10, 2026, and could lead to better sun protection options without extra costs for consumers.
Previous / Next Documents
Previous: 2025-24268 — Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON
The FDA has officially set the review period for MEDIBEACON, a medical device, which helps the company apply for extra patent time. This means the makers can potentially extend their patent protection, giving them more time to benefit financially. Anyone interested has until March 6, 2026, to share their thoughts with the FDA.
Next: 2025-24270 — Determination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO
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.