Prothrombin complex concentrate, human-lans (Balfaxar)
Prothrombin complex concentrate, human-lans is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Balfaxar Prothrombin complex concentrate, human-lans
Octapharma Pharmazeutika Produktionsges.m.b.H.
- Approved
- Jul 21, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Prothrombin complex concentrate, human-lans, in chronological order.
Reference approval
Approval date of the reference Prothrombin complex concentrate, human-lans product.
2 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for Prothrombin complex concentrate, human-lans (Balfaxar)?
No 351(k) biosimilars or interchangeable biosimilars referencing Prothrombin complex concentrate, human-lans are listed in the FDA Purple Book yet.
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