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Purple Book reference family · 351(a) biologic

Fibrinogen (Human) (Fibryga)

Fibrinogen (Human) is an FDA-licensed reference biologic from Octapharma Pharmazeutika Produktionsges.m.b.H..

351(a) biologicBLA 125612 Octapharma Pharmazeutika Produktionsges.m.b.H.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017

Reference product

Originator biologic
351(a)BLA 125612

Fibryga Fibrinogen (Human)

Octapharma Pharmazeutika Produktionsges.m.b.H.

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for Fibrinogen (Human) from the RCSB Protein Data Bank (PDB 3GHG).

3D molecular structure of Fibrinogen (Human) (PDB entry 3GHG)

Interactive biological assembly from PDB entry 3GHG. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Fibrinogen (Human) product.

    9 yr 5 mo ago

Fibrinogen (Human): 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 Fibrinogen (Human).

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Agent CTA Background

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