FDA Clocks Review Time for HYMPAVZI Patent Boost
Published Date: 4/3/2026
Notice
Summary
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
FDA OKs HYMPAVZI Patent Extension Bid
FDA has set the official regulatory review period for HYMPAVZI so the patent holder can apply for extra patent time. The notice explains the patent applicant (Pfizer Inc.) may pursue patent term restoration based on FDA's determination.
Regulatory Review Period Length Confirmed
FDA determined the regulatory review period for HYMPAVZI is 2,858 days total (2,491 days testing phase; 367 days approval phase). Key dates FDA verified are: IND effective December 16, 2016; BLA submitted October 11, 2023; BLA approved October 11, 2024; the applicant seeks 462 days of patent extension.
HYMPAVZI Approved for Hemophilia A and B
FDA approved HYMPAVZI (marstacimab-hncq) for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. The approval is referenced in FDA's regulatory review period determination.
Public Deadlines to Challenge Dates or Diligence
Anyone who believes the published dates are incorrect may request redetermination by June 2, 2026, and any interested person may petition FDA about whether the applicant acted with due diligence by September 30, 2026. The notice explains how to submit comments or petitions electronically or by mail.
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Key Dates
Department and Agencies
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