Factor XIII Concentrate (Human) (Corifact)
Factor XIII Concentrate (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
2011
Reference approved
Reference product
Corifact Factor XIII Concentrate (Human)
CSL Behring GmbH
- Approved
- Feb 17, 2011
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Factor XIII Concentrate (Human), in chronological order.
Reference approval
Approval date of the reference Factor XIII Concentrate (Human) product.
15 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
6 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Factor XIII Concentrate (Human) (Corifact)?
No 351(k) biosimilars or interchangeable biosimilars referencing Factor XIII Concentrate (Human) are listed in the FDA Purple Book yet.
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