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Purple Book reference family · 351(a) biologic

infliximab-dyyb (Zymfentra)

infliximab-dyyb is an FDA-licensed reference biologic from CELLTRION, Inc..

351(a) biologicBLA 761358 CELLTRION, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023

Reference product

Originator biologic
351(a)BLA 761358

Zymfentra infliximab-dyyb

CELLTRION, Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for infliximab-dyyb from the RCSB Protein Data Bank (PDB 5VH3).

3D molecular structure of infliximab-dyyb (PDB entry 5VH3)

Interactive biological assembly from PDB entry 5VH3. 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 infliximab-dyyb product.

    3 yr ago

infliximab-dyyb: 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 infliximab-dyyb.

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Agent CTA Background

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