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Purple Book reference family · 351(a) biologic

tocilizumab (Actemra)

tocilizumab is an FDA-licensed reference biologic from Genentech, Inc., with 3 approved follow-on biologics.

351(a) biologicBLA 125276 Genentech, Inc.
Biosimilars
3
Interchangeables
0
Listed patents
35
Reference approved
2010

Reference product

Originator biologic
351(a)BLA 125276

Actemra tocilizumab

Genentech, Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for tocilizumab from the RCSB Protein Data Bank (PDB 8J6F).

3D molecular structure of tocilizumab (PDB entry 8J6F)

Interactive biological assembly from PDB entry 8J6F. 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 8J6F details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference tocilizumab product.

    16 yr 11 mo ago

  2. Patent 7,332,289 expires

    Published Purple Book patent expiration.

    3 yr 2 mo ago

  3. Patent 10,744,201 expires

    Published Purple Book patent expiration.

    2 yr 5 mo ago

  4. Patent 7,521,052 expires

    Published Purple Book patent expiration.

    2 yr 5 mo ago

  5. Patent 8,709,409 expires

    Published Purple Book patent expiration.

    2 yr 3 mo ago

  6. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    1 yr 7 mo ago

  7. Patent 8,734,800 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  8. Patent 9,902,777 expires

    Published Purple Book patent expiration.

    1 yr 4 mo ago

  9. Patent 8,617,550 expires

    Published Purple Book patent expiration.

    7 mo ago

  10. Patent 8,398,980 expires

    Published Purple Book patent expiration.

    in 1 yr 5 mo

  11. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  12. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 1 yr 10 mo

  13. Patent 11,008,394 expires

    Published Purple Book patent expiration.

    in 2 yr 4 mo

  14. Patent 11,359,026 expires

    Published Purple Book patent expiration.

    in 2 yr 4 mo

  15. Patent 11,584,798 expires

    Published Purple Book patent expiration.

    in 2 yr 4 mo

  16. Patent 11,136,375 expires

    Published Purple Book patent expiration.

    in 2 yr 10 mo

  17. Patent 8,568,720 expires

    Published Purple Book patent expiration.

    in 3 yr 2 mo

  18. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  19. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 3 yr 11 mo

  20. Patent 10,501,769 expires

    Published Purple Book patent expiration.

    in 4 yr 2 mo

  21. Patent 11,021,728 expires

    Published Purple Book patent expiration.

    in 4 yr 2 mo

  22. Patent 11,136,610 expires

    Published Purple Book patent expiration.

    in 4 yr 2 mo

  23. Patent 11,377,678 expires

    Published Purple Book patent expiration.

    in 4 yr 2 mo

  24. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 4 mo

  25. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  26. Patent 11,667,720 expires

    Published Purple Book patent expiration.

    in 5 yr 2 mo

  27. Patent 8,580,264 expires

    Published Purple Book patent expiration.

    in 5 yr 2 mo

  28. Patent 10,231,981 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  29. Patent 10,874,677 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  30. Patent 9,539,263 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  31. Patent 9,750,752 expires

    Published Purple Book patent expiration.

    in 6 yr

  32. Patent 10,590,164 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  33. Patent 9,630,988 expires

    Published Purple Book patent expiration.

    in 6 yr 10 mo

  34. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  35. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  36. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  37. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 9 yr

Biosimilars & interchangeables for tocilizumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing tocilizumab.
ProductProper nameApplicantTypeBLAApproved
Tofidencetocilizumab-baviBiogen MA Inc.Biosimilar 351(k)761354
Tyennetocilizumab-aazgFresenius Kabi USA, LLCBiosimilar 351(k)761275
Avtozmatocilizumab-anohCELLTRION, Inc.Biosimilar 351(k)761498

Published patents

Purple Book patent list
Published Purple Book patents for tocilizumab.
PatentExpiresIn
7,332,2893 yr 2 mo ago
10,744,2012 yr 5 mo ago
7,521,0522 yr 5 mo ago
8,709,4092 yr 3 mo ago
8,734,8001 yr 6 mo ago
9,902,7771 yr 4 mo ago
8,617,5507 mo ago
8,398,980in 1 yr 5 mo
11,078,294in 1 yr 10 mo
8,574,869in 1 yr 10 mo
11,008,394in 2 yr 4 mo
11,359,026in 2 yr 4 mo
11,584,798in 2 yr 4 mo
11,136,375in 2 yr 10 mo
8,568,720in 3 yr 2 mo
10,982,003in 3 yr 11 mo
9,714,293in 3 yr 11 mo
10,501,769in 4 yr 2 mo
11,021,728in 4 yr 2 mo
11,136,610in 4 yr 2 mo
11,377,678in 4 yr 2 mo
8,512,983in 4 yr 4 mo
10,662,237in 4 yr 11 mo
11,667,720in 5 yr 2 mo
8,580,264in 5 yr 2 mo
10,231,981in 5 yr 3 mo
10,874,677in 5 yr 6 mo
9,539,263in 5 yr 9 mo
9,750,752in 6 yr
10,590,164in 6 yr 7 mo
9,630,988in 6 yr 10 mo
10,676,710in 7 yr 7 mo
10,829,732in 7 yr 7 mo
10,017,732in 8 yr 5 mo
10,336,983in 9 yr

tocilizumab: 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 tocilizumab.

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