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FDA Purple Book · Reference family

acellular nerve allograft-arwx (avance nerve graft)

acellular nerve allograft-arwx is an FDA-licensed reference biologic from Axogen Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 125816

avance nerve graft acellular nerve allograft-arwx

Axogen Corporation

Approved
Dec 03, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for acellular nerve allograft-arwx, in chronological order.

  1. Reference approval

    Approval date of the reference acellular nerve allograft-arwx product.

    6 mo ago

Frequently asked questions

Are there biosimilars approved for acellular nerve allograft-arwx (avance nerve graft)?

No 351(k) biosimilars or interchangeable biosimilars referencing acellular nerve allograft-arwx are listed in the FDA Purple Book yet.

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