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FDA Purple Book · Reference family

acellular tissue engineered vessel-tyod (symvess)

acellular tissue engineered vessel-tyod is an FDA-licensed reference biologic from Humacyte Global Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2024

Reference approved

Reference product

351(a)BLA 125812

symvess acellular tissue engineered vessel-tyod

Humacyte Global Inc.

Approved
Dec 19, 2024
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for acellular tissue engineered vessel-tyod, in chronological order.

  1. First licensure

    Date acellular tissue engineered vessel-tyod was first licensed by the FDA.

    1 yr 6 mo ago

  2. Reference approval

    Approval date of the reference acellular tissue engineered vessel-tyod product.

    1 yr 6 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    in 10 yr 8 mo

Frequently asked questions

Are there biosimilars approved for acellular tissue engineered vessel-tyod (symvess)?

No 351(k) biosimilars or interchangeable biosimilars referencing acellular tissue engineered vessel-tyod are listed in the FDA Purple Book yet.

When does acellular tissue engineered vessel-tyod (symvess) lose reference-product exclusivity?

acellular tissue engineered vessel-tyod's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending December 19, 2036.

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