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
Molecular structure
Experimental 3D structure for C1 Esterase Inhibitor (Human) from the RCSB Protein Data Bank (PDB 5DU3).
Interactive biological assembly from PDB entry 5DU3. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
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.
17 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
9 yr 11 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.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.