Purple Book product · Reference 351(a)

symvess

acellular tissue engineered vessel-tyod

351(a)BLA 125812RxLicensed Humacyte Global Inc.

View acellular tissue engineered vessel-tyod family Label PDF Open on FDA Purple Book

Dec 19, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

symvess (acellular tissue engineered vessel-tyod) is Humacyte Global Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing symvess are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Dec 19, 1936.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Dec 19, 1936
90 yr 11 mo ago
First licensure
Date the BLA was first licensed.
Dec 19, 2024
1 yr 7 mo ago
Approval
Approval date of this BLA submission.
Dec 19, 2024
1 yr 7 mo ago
Today

Pharmaceutical detail

Strength

6 MM IN INNER DIAMETER,~42 CM LENGTH

Dosage form

Implant

Route

Implantation

Presentation

Tray & Lid

Center

CBER

License number

2336

Product number

001

Submission type

Original

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does symvess have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing symvess are listed in the FDA Purple Book yet.

When does symvess lose reference-product exclusivity?

symvess's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Dec 19, 1936.

What is symvess's BLA number?

symvess is licensed under BLA 125812, held by Humacyte Global Inc..

When was symvess approved by the FDA?

symvess was first licensed by the FDA on Dec 19, 2024.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo