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Purple Book reference family · 351(a) biologic

bevacizumab (Avastin)

bevacizumab is an FDA-licensed reference biologic from Genentech, Inc., with 6 approved follow-on biologics.

351(a) biologicBLA 125085 Genentech, Inc.
Biosimilars
6
Interchangeables
0
Listed patents
22
Reference approved
2004

Reference product

Originator biologic
351(a)BLA 125085

Avastin bevacizumab

Genentech, Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
22 listed

Molecular structure

RCSB Protein Data Bank

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, with no need to leave the page.

Open in RCSB viewer PDB 7V5N details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference bevacizumab product.

    22 yr 11 mo ago

  2. Patent 9,795,672 expires

    Published Purple Book patent expiration.

    2 yr 5 mo ago

  3. Patent 7,485,704 expires

    Published Purple Book patent expiration.

    1 yr 7 mo ago

  4. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 8 mo

  5. Patent 10,906,986 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  6. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  7. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  8. Patent 8,460,895 expires

    Published Purple Book patent expiration.

    in 2 yr 10 mo

  9. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  10. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  11. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 4 mo

  12. Patent 10,011,856 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  13. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  14. Patent 10,704,071 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  15. Patent 9,487,809 expires

    Published Purple Book patent expiration.

    in 5 yr 4 mo

  16. Patent 10,513,697 expires

    Published Purple Book patent expiration.

    in 6 yr

  17. Patent 10,906,934 expires

    Published Purple Book patent expiration.

    in 7 yr 1 mo

  18. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 7 yr 6 mo

  19. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 6 mo

  20. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 6 mo

  21. Patent 9,441,035 expires

    Published Purple Book patent expiration.

    in 7 yr 8 mo

  22. Patent 10,274,466 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

  23. Patent 10,208,355 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

  24. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 8 yr 11 mo

Biosimilars & interchangeables for bevacizumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing bevacizumab.
ProductProper nameApplicantTypeBLAApproved
Mvasibevacizumab-awwbAmgen Inc.Biosimilar 351(k)761028
Zirabevbevacizumab-bvzrPfizer Inc.Biosimilar 351(k)761099
Alymsysbevacizumab-malyAmneal Pharmaceuticals LLCBiosimilar 351(k)761231
Vegzelmabevacizumab-adcdCELLTRION, Inc.Biosimilar 351(k)761268
Avzivibevacizumab-tnjnBio-Thera Solutions, Ltd.Biosimilar 351(k)761198
Jobevnebevacizumab-nwgdBiocon Biologics Inc.Biosimilar 351(k)761175

Published patents

Purple Book patent list
Published Purple Book patents for bevacizumab.
PatentExpiresIn
9,795,6722 yr 5 mo ago
7,485,7041 yr 7 mo ago
10,906,986in 1 yr 9 mo
11,078,294in 1 yr 9 mo
8,574,869in 1 yr 9 mo
8,460,895in 2 yr 10 mo
10,982,003in 3 yr 11 mo
9,714,293in 3 yr 11 mo
8,512,983in 4 yr 4 mo
10,011,856in 4 yr 8 mo
10,662,237in 4 yr 11 mo
10,704,071in 4 yr 11 mo
9,487,809in 5 yr 4 mo
10,513,697in 6 yr
10,906,934in 7 yr 1 mo
10,017,732in 7 yr 6 mo
10,676,710in 7 yr 6 mo
10,829,732in 7 yr 6 mo
9,441,035in 7 yr 8 mo
10,274,466in 8 yr 11 mo
10,208,355in 8 yr 11 mo
10,336,983in 8 yr 11 mo

bevacizumab: 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 bevacizumab.

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