Purple Book reference family · 351(a) biologic
zopapogene imadenovec-drba (PAPZIMEOS)
zopapogene imadenovec-drba is an FDA-licensed reference biologic from Precigen, Inc..
351(a) biologicBLA 125832 Precigen, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125832
PAPZIMEOS zopapogene imadenovec-drba
Precigen, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
95 yr 4 mo ago
Reference approval
Approval date of the reference zopapogene imadenovec-drba product.
1 yr ago
zopapogene imadenovec-drba: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for zopapogene imadenovec-drba.
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