FDA Sets Clock for SYMVESS Patent Extension Review
Published Date: 2/19/2026
Notice
Summary
The FDA has set the official review period for SYMVESS, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind SYMVESS and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until April 20 or August 18, 2026, to speak up—potentially impacting patent length and market exclusivity.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA sets SYMVESS review period
If you are the patent holder (Humacyte Global, Inc.), FDA has determined the regulatory review period for SYMVESS is 3,069 days total: 2,694 days in the testing phase and 375 days in the approval phase. FDA lists the key dates as an IND effective July 27, 2016, a BLA submission on December 11, 2023, and approval on December 19, 2024; the applicant requests 1,572 days of patent term extension and the FDA determination establishes the product's maximum potential extension length before USPTO applies statutory limits.
Deadlines to challenge SYMVESS dates
Anyone who thinks the dates are wrong may ask FDA for a redetermination by April 20, 2026, and anyone may petition FDA about whether the applicant acted with due diligence by August 18, 2026. Petitions must follow FDA rules (21 CFR 60.24 and 21 CFR 60.30) and be filed electronically or by written submission as described in the notice.
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Key Dates
Department and Agencies
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