Purple Book product · Reference 351(a)
PAPZIMEOS
zopapogene imadenovec-drba
Aug 14, 2025
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 14, 1932
95 yr 3 mo ago
Approval
Approval date of this BLA submission.
Aug 14, 2025
11 mo ago
Today
Pharmaceutical detail
Strength
5x10^11PARTICLE UNITS
Dosage form
For Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CBER
License number
2364
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v7Jul 02, 2026
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does PAPZIMEOS have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing PAPZIMEOS are listed in the FDA Purple Book yet.
What is PAPZIMEOS's BLA number?
PAPZIMEOS is licensed under BLA 125832, held by Precigen, Inc..
When was PAPZIMEOS approved by the FDA?
PAPZIMEOS was approved by the FDA on Aug 14, 2025.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
