FDA Purple Book · Reference family
garadacimab-gxii (Andembry)
garadacimab-gxii is an FDA-licensed reference biologic from CSL Behring LLC. 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 761367
Andembry garadacimab-gxii
CSL Behring LLC
- Approved
- Jun 16, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for garadacimab-gxii, in chronological order.
Reference approval
Approval date of the reference garadacimab-gxii product.
1 yr ago
Frequently asked questions
Are there biosimilars approved for garadacimab-gxii (Andembry)?
No 351(k) biosimilars or interchangeable biosimilars referencing garadacimab-gxii are listed in the FDA Purple Book yet.
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