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FDA Purple Book · Reference family

bevacizumab (Avastin)

bevacizumab is an FDA-licensed reference biologic from Genentech, Inc., with 6 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

6

Biosimilars

0

Interchangeables

22

Listed patents

2004

Reference approved

Reference product

351(a)BLA 125085

Avastin bevacizumab

Genentech, Inc.

Approved
Feb 26, 2004
Marketing
Rx
Center
CDER
Patents
22 listed

Molecular structure

Experimental 3D structure for bevacizumab from the RCSB Protein Data Bank (PDB 7V5N).

3D molecular structure of bevacizumab (PDB entry 7V5N)

Interactive biological assembly from PDB entry 7V5N. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.

Open in RCSB viewer PDB 7V5N details

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference bevacizumab product.

    22 yr 7 mo ago

  2. Patent 9,795,672 expires

    Published Purple Book patent expiration.

    2 yr ago

  3. Patent 7,485,704 expires

    Published Purple Book patent expiration.

    1 yr 3 mo ago

  4. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr

  5. Patent 10,906,986 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  6. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  7. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  8. Patent 8,460,895 expires

    Published Purple Book patent expiration.

    in 3 yr 3 mo

  9. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  10. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  11. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  12. Patent 10,011,856 expires

    Published Purple Book patent expiration.

    in 5 yr 1 mo

  13. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  14. Patent 10,704,071 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  15. Patent 9,487,809 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  16. Patent 10,513,697 expires

    Published Purple Book patent expiration.

    in 6 yr 5 mo

  17. Patent 10,906,934 expires

    Published Purple Book patent expiration.

    in 7 yr 6 mo

  18. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  19. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  20. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  21. Patent 9,441,035 expires

    Published Purple Book patent expiration.

    in 8 yr

  22. Patent 10,274,466 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  23. Patent 10,208,355 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  24. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

Biosimilars & interchangeables for bevacizumab

6 FDA-licensed follow-on biologics referencing bevacizumab.

Biosimilars and interchangeable biosimilars referencing bevacizumab.
ProductProper nameApplicantTypeBLAApproved
Mvasibevacizumab-awwbAmgen Inc.Biosimilar 351(k)761028Sep 14, 2017
Zirabevbevacizumab-bvzrPfizer Inc.Biosimilar 351(k)761099Jun 27, 2019
Alymsysbevacizumab-malyAmneal Pharmaceuticals LLCBiosimilar 351(k)761231Apr 13, 2022
Vegzelmabevacizumab-adcdCELLTRION, Inc.Biosimilar 351(k)761268Sep 27, 2022
Avzivibevacizumab-tnjnBio-Thera Solutions, Ltd.Biosimilar 351(k)761198Dec 06, 2023
Jobevnebevacizumab-nwgdBiocon Biologics Inc.Biosimilar 351(k)761175Apr 09, 2025

Published patents

Patents the BLA holder has published in the FDA Purple Book Patent List for bevacizumab.

Published Purple Book patents for bevacizumab.
PatentExpiresIn
9,795,672May 28, 20242 yr ago
7,485,704Mar 08, 20251 yr 3 mo ago
10,906,986Jul 08, 2028in 2 yr 2 mo
11,078,294Jul 08, 2028in 2 yr 2 mo
8,574,869Jul 08, 2028in 2 yr 2 mo
8,460,895Aug 08, 2029in 3 yr 3 mo
10,982,003Aug 06, 2030in 4 yr 3 mo
9,714,293Aug 06, 2030in 4 yr 3 mo
8,512,983Jan 04, 2031in 4 yr 8 mo
10,011,856May 26, 2031in 5 yr 1 mo
10,662,237Aug 07, 2031in 5 yr 3 mo
10,704,071Aug 18, 2031in 5 yr 3 mo
9,487,809Jan 14, 2032in 5 yr 8 mo
10,513,697Sep 17, 2032in 6 yr 5 mo
10,906,934Oct 12, 2033in 7 yr 6 mo
10,017,732Mar 14, 2034in 7 yr 11 mo
10,676,710Mar 14, 2034in 7 yr 11 mo
10,829,732Mar 14, 2034in 7 yr 11 mo
9,441,035Apr 23, 2034in 8 yr
10,274,466Jul 11, 2035in 9 yr 3 mo
10,208,355Jul 14, 2035in 9 yr 3 mo
10,336,983Jul 31, 2035in 9 yr 4 mo

Frequently asked questions

What biosimilars are approved for bevacizumab (Avastin)?

The FDA Purple Book lists 6 approved follow-on biologics referencing bevacizumab: Mvasi, Zirabev, Alymsys, Vegzelma, Avzivi, and Jobevne. Of these, 0 are interchangeable biosimilars and 6 are 351(k) biosimilars.

Who makes bevacizumab biosimilars?

Companies with FDA-approved follow-on biologics referencing bevacizumab include Amgen Inc., Pfizer Inc., Amneal Pharmaceuticals LLC, CELLTRION, Inc., Bio-Thera Solutions, Ltd., and Biocon Biologics Inc..

How many patents are listed for bevacizumab (Avastin) in the Purple Book?

22 patents are published in the FDA Purple Book Patent List for bevacizumab.

Explore the full FDA Purple Book

Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.

Open the Purple Book tool