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.
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
2026-09767 — Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He ignored the chance to defend himself, so the ban started on May 15, 2026. This means no drug imports from him for a while, but he can apply to end the ban anytime if he meets FDA’s conditions.
2026-09448 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
The FDA is asking for approval to collect info for the third group in its Real Cost Campaign, which teaches kids about the dangers of tobacco. This helps the FDA improve its anti-smoking messages and protect young people’s health. Comments on this info collection are open until June 12, 2026, with no new costs for participants.
2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This affects drug makers and healthcare folks who keep track of side effects. They’re asking for comments by July 13, 2026, to help improve the process without adding extra costs or paperwork.
2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If approved, the renewal keeps these products on the market with their modified risk status, affecting smokers and the tobacco industry starting May 13, 2026.
2026-09335 — Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
Hey there! This update is all about a new medical device that helps doctors quickly find germs and their resistance traits in people who might have bone infections. It affects hospitals and labs by officially classifying this device, making it easier and faster to diagnose tough infections. The change kicks in soon, helping patients get the right treatment without delay—and it could save money by avoiding wrong meds!
2026-09368 — Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability
The FDA is setting clear rules for certain new tobacco products like e-cigarettes and nicotine pouches that don’t have official approval yet. Companies selling these products without permission might face enforcement actions starting now, so they need to get authorized or risk penalties. This helps protect public health and keeps the market fair and safe.
Previous / Next Documents
Previous: 2026-03311 — Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The FDA wants your thoughts on how they collect info about safely processing and importing fish and seafood. This affects businesses that handle fish products, aiming to keep seafood safe and clean. You’ve got until April 20, 2026, to share your comments—no fees, just your voice helping shape safer seafood rules!
Next: 2026-03313 — Agency Information Collection Request. 60-Day Public Comment Request
The Department of Health and Human Services’ Office of Minority Health wants your thoughts on keeping their Think Cultural Health info collection going—no changes, just a renewal. This helps health pros sign up for courses and earn credits to better serve diverse communities. You’ve got until April 21, 2026, to share your comments, and there’s no new cost involved.