Determination of Regulatory Review Period for Purposes of Patent Extension; BEQVEZ
Published Date: 2/6/2026
Notice
Summary
The FDA has set the official review period for BEQVEZ, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind BEQVEZ and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s effort during review, you have until early August 2026 to speak up—no money changes hands now, but this could impact how long the patent lasts.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Sets BEQVEZ Review Period
FDA determined the regulatory review period for BEQVEZ is 3,277 days total — 2,913 days in the testing phase and 364 days in the approval phase. Key dates used were: IND effective May 8, 2015; biologics license application initially submitted April 28, 2023; and approval on April 25, 2024. This FDA determination establishes the maximum potential patent-extension period; the patent applicant is seeking 671 days of patent term extension and the USPTO will apply statutory limits in its final calculation.
Deadlines to Challenge BEQVEZ Dates
If you believe the published dates are incorrect, you must submit comments asking for a redetermination by April 7, 2026. Any interested person may petition FDA to determine whether the applicant acted with due diligence during the regulatory review period by August 5, 2026; petitions must meet the requirements of 21 CFR 60.30 and be served on the patent applicant.
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