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Purple Book reference family · 351(a) biologic

Fibrinogen Concentrate (Human) (Riastap)

Fibrinogen Concentrate (Human) is an FDA-licensed reference biologic from CSL Behring GmbH.

351(a) biologicBLA 125317 CSL Behring GmbH
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2009

Reference product

Originator biologic
351(a)BLA 125317

Riastap Fibrinogen Concentrate (Human)

CSL Behring GmbH

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

Molecular structure

RCSB Protein Data Bank

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

3D molecular structure of Fibrinogen Concentrate (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.

Open in RCSB viewer PDB 3GHG details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference Fibrinogen Concentrate (Human) product.

    18 yr ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    10 yr 11 mo ago

Fibrinogen Concentrate (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 Concentrate (Human).

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