Purple Book reference family · 351(a) biologic
Prothrombin complex concentrate, human-lans (Balfaxar)
Prothrombin complex concentrate, human-lans is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H..
351(a) biologicBLA 125776 Octapharma Pharmazeutika Produktionsges.m.b.H.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 125776
Balfaxar Prothrombin complex concentrate, human-lans
Octapharma Pharmazeutika Produktionsges.m.b.H.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Prothrombin complex concentrate, human-lans product.
3 yr 1 mo ago
Prothrombin complex concentrate, human-lans: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Prothrombin complex concentrate, human-lans.
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