C1 Esterase Inhibitor Subcutaneous (Human) (Haegarda)
C1 Esterase Inhibitor Subcutaneous (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
2017
Reference approved
Reference product
Haegarda C1 Esterase Inhibitor Subcutaneous (Human)
CSL Behring GmbH
- Approved
- Jun 22, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for C1 Esterase Inhibitor Subcutaneous (Human), in chronological order.
Reference approval
Approval date of the reference C1 Esterase Inhibitor Subcutaneous (Human) product.
9 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
2 yr ago
Frequently asked questions
Are there biosimilars approved for C1 Esterase Inhibitor Subcutaneous (Human) (Haegarda)?
No 351(k) biosimilars or interchangeable biosimilars referencing C1 Esterase Inhibitor Subcutaneous (Human) are listed in the FDA Purple Book yet.
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