Fibrinogen Concentrate (Human) (Riastap)
Fibrinogen 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
2009
Reference approved
Reference product
Riastap Fibrinogen Concentrate (Human)
CSL Behring GmbH
- Approved
- Jan 16, 2009
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Fibrinogen Concentrate (Human), in chronological order.
Reference approval
Approval date of the reference Fibrinogen Concentrate (Human) product.
17 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
10 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Fibrinogen Concentrate (Human) (Riastap)?
No 351(k) biosimilars or interchangeable biosimilars referencing Fibrinogen Concentrate (Human) are listed in the FDA Purple Book yet.
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