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FDA Purple Book · Reference family

atezolizumab (Tecentriq)

atezolizumab 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

2016

Reference approved

Reference product

351(a)BLA 761034

Tecentriq atezolizumab

Genentech, Inc.

Approved
May 18, 2016
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

Experimental 3D structure for atezolizumab from the RCSB Protein Data Bank (PDB 5XXY).

3D molecular structure of atezolizumab (PDB entry 5XXY)

Interactive biological assembly from PDB entry 5XXY. 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 atezolizumab, in chronological order.

  1. Reference approval

    Approval date of the reference atezolizumab product.

    10 yr 2 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 3 yr 7 mo

Frequently asked questions

Are there biosimilars approved for atezolizumab (Tecentriq)?

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

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