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Purple Book reference family · 351(a) biologic

Factor XIII Concentrate (Human) (Corifact)

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

351(a) biologicBLA 125385 CSL Behring GmbH
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011

Reference product

Originator biologic
351(a)BLA 125385

Corifact Factor XIII 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 Factor XIII Concentrate (Human) from the RCSB Protein Data Bank (PDB 1GGT).

3D molecular structure of Factor XIII Concentrate (Human) (PDB entry 1GGT)

Interactive biological assembly from PDB entry 1GGT. 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 Factor XIII Concentrate (Human) product.

    15 yr 10 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    6 yr 9 mo ago

Factor XIII 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 Factor XIII Concentrate (Human).

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