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).

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
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.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

