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FDA Purple Book · Reference family

Prademagene zamikeracel (zevaskyn)

Prademagene zamikeracel is an FDA-licensed reference biologic from Abeona Therapeutics Inc.. 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 125807

zevaskyn Prademagene zamikeracel

Abeona Therapeutics Inc.

Approved
Apr 28, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Prademagene zamikeracel, in chronological order.

  1. Reference approval

    Approval date of the reference Prademagene zamikeracel product.

    1 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for Prademagene zamikeracel (zevaskyn)?

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

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