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FDA Purple Book · Reference family

zopapogene imadenovec-drba (PAPZIMEOS)

zopapogene imadenovec-drba is an FDA-licensed reference biologic from Precigen, 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 125832

PAPZIMEOS zopapogene imadenovec-drba

Precigen, Inc.

Approved
Aug 14, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for zopapogene imadenovec-drba, in chronological order.

  1. Reference approval

    Approval date of the reference zopapogene imadenovec-drba product.

    10 mo ago

Frequently asked questions

Are there biosimilars approved for zopapogene imadenovec-drba (PAPZIMEOS)?

No 351(k) biosimilars or interchangeable biosimilars referencing zopapogene imadenovec-drba are listed in the FDA Purple Book yet.

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