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).
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Key Dates
Department and Agencies
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