C1 Esterase Inhibitor (Human) (Berinert)
C1 Esterase Inhibitor (Human) is an FDA-licensed reference biologic from CSL Behring GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Berinert C1 Esterase Inhibitor (Human)
CSL Behring GmbH
- Approved
- Oct 09, 2009
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for C1 Esterase Inhibitor (Human), in chronological order.
Reference approval
Approval date of the reference C1 Esterase Inhibitor (Human) product.
16 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
9 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for C1 Esterase Inhibitor (Human) (Berinert)?
No 351(k) biosimilars or interchangeable biosimilars referencing C1 Esterase Inhibitor (Human) are listed in the FDA Purple Book yet.
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