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Purple Book reference family · 351(a) biologic

Antihemophilic Factor (Recombinant), Full Length (Kovaltry)

Antihemophilic Factor (Recombinant), Full Length is an FDA-licensed reference biologic from Bayer HealthCare LLC.

351(a) biologicBLA 125574 Bayer HealthCare LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016

Reference product

Originator biologic
351(a)BLA 125574

Kovaltry Antihemophilic Factor (Recombinant), Full Length

Bayer HealthCare LLC

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for Antihemophilic Factor (Recombinant), Full Length from the RCSB Protein Data Bank (PDB 3CDZ).

3D molecular structure of Antihemophilic Factor (Recombinant), Full Length (PDB entry 3CDZ)

Interactive biological assembly from PDB entry 3CDZ. 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 Antihemophilic Factor (Recombinant), Full Length product.

    10 yr 8 mo ago

Antihemophilic Factor (Recombinant), Full Length: 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 Antihemophilic Factor (Recombinant), Full Length.

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