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FDA Purple Book · Reference family

efalizumab (Raptiva)

efalizumab is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2003

Reference approved

Reference product

351(a)BLA 125075

Raptiva efalizumab

Genentech, Inc.

Approved
Oct 27, 2003
Marketing
Disc
Center
CDER
Patents
None listed

Molecular structure

Experimental 3D structure for efalizumab from the RCSB Protein Data Bank (PDB 3EO9).

3D molecular structure of efalizumab (PDB entry 3EO9)

Interactive biological assembly from PDB entry 3EO9. 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 efalizumab, in chronological order.

  1. Reference approval

    Approval date of the reference efalizumab product.

    22 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for efalizumab (Raptiva)?

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

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