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Purple Book reference family · 351(a) biologic

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (Advate)

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..

351(a) biologicBLA 125063 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2003

Reference product

Originator biologic
351(a)BLA 125063

Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method

Takeda Pharmaceuticals U.S.A., Inc.

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), Plasma/Albumin Free Method from the RCSB Protein Data Bank (PDB 3CDZ).

3D molecular structure of Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (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), Plasma/Albumin Free Method product.

    23 yr 6 mo ago

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method: 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), Plasma/Albumin Free Method.

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