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Purple Book reference family · 351(a) biologic

ansuvimab-zykl (Ebanga)

ansuvimab-zykl is an FDA-licensed reference biologic from Emergent Manufacturing Operations Baltimore LLC.

351(a) biologicBLA 761172 Emergent Manufacturing Operations Baltimore LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020

Reference product

Originator biologic
351(a)BLA 761172

Ebanga ansuvimab-zykl

Emergent Manufacturing Operations Baltimore LLC

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for ansuvimab-zykl from the RCSB Protein Data Bank (PDB 5FHC).

3D molecular structure of ansuvimab-zykl (PDB entry 5FHC)

Interactive biological assembly from PDB entry 5FHC. 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 ansuvimab-zykl product.

    5 yr 10 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr 3 mo

ansuvimab-zykl: 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 ansuvimab-zykl.

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