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FDA Purple Book · Reference family

daclizumab (Zenapax)

daclizumab is an FDA-licensed reference biologic from Hoffmann-La Roche Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1997

Reference approved

Reference product

351(a)BLA 103749

Zenapax daclizumab

Hoffmann-La Roche Inc.

Approved
Dec 10, 1997
Marketing
Disc
Center
CDER
Patents
None listed

Molecular structure

Experimental 3D structure for daclizumab from the RCSB Protein Data Bank (PDB 3NFS).

3D molecular structure of daclizumab (PDB entry 3NFS)

Interactive biological assembly from PDB entry 3NFS. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for daclizumab, in chronological order.

  1. Reference approval

    Approval date of the reference daclizumab product.

    28 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for daclizumab (Zenapax)?

No 351(k) biosimilars or interchangeable biosimilars referencing daclizumab are listed in the FDA Purple Book yet.

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