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FDA Purple Book · Reference family

tocilizumab (Actemra)

tocilizumab is an FDA-licensed reference biologic from Genentech, Inc., with 3 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

3

Biosimilars

0

Interchangeables

35

Listed patents

2010

Reference approved

Reference product

351(a)BLA 125276

Actemra tocilizumab

Genentech, Inc.

Approved
Jan 08, 2010
Marketing
Rx
Center
CDER
Patents
35 listed

Molecular structure

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 — no need to leave the page.

Open in RCSB viewer PDB 8J6F details

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference tocilizumab product.

    16 yr 8 mo ago

  2. Patent 7,332,289 expires

    Published Purple Book patent expiration.

    2 yr 10 mo ago

  3. Patent 10,744,201 expires

    Published Purple Book patent expiration.

    2 yr 1 mo ago

  4. Patent 7,521,052 expires

    Published Purple Book patent expiration.

    2 yr 1 mo ago

  5. Patent 8,709,409 expires

    Published Purple Book patent expiration.

    2 yr ago

  6. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    1 yr 3 mo ago

  7. Patent 8,734,800 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  8. Patent 9,902,777 expires

    Published Purple Book patent expiration.

    1 yr ago

  9. Patent 8,617,550 expires

    Published Purple Book patent expiration.

    3 mo ago

  10. Patent 8,398,980 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  11. Patent 11,078,294 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  12. Patent 8,574,869 expires

    Published Purple Book patent expiration.

    in 2 yr 2 mo

  13. Patent 11,008,394 expires

    Published Purple Book patent expiration.

    in 2 yr 7 mo

  14. Patent 11,359,026 expires

    Published Purple Book patent expiration.

    in 2 yr 7 mo

  15. Patent 11,584,798 expires

    Published Purple Book patent expiration.

    in 2 yr 7 mo

  16. Patent 11,136,375 expires

    Published Purple Book patent expiration.

    in 3 yr 2 mo

  17. Patent 8,568,720 expires

    Published Purple Book patent expiration.

    in 3 yr 6 mo

  18. Patent 10,982,003 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  19. Patent 9,714,293 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  20. Patent 10,501,769 expires

    Published Purple Book patent expiration.

    in 4 yr 6 mo

  21. Patent 11,021,728 expires

    Published Purple Book patent expiration.

    in 4 yr 6 mo

  22. Patent 11,136,610 expires

    Published Purple Book patent expiration.

    in 4 yr 6 mo

  23. Patent 11,377,678 expires

    Published Purple Book patent expiration.

    in 4 yr 6 mo

  24. Patent 8,512,983 expires

    Published Purple Book patent expiration.

    in 4 yr 8 mo

  25. Patent 10,662,237 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  26. Patent 11,667,720 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  27. Patent 8,580,264 expires

    Published Purple Book patent expiration.

    in 5 yr 6 mo

  28. Patent 10,231,981 expires

    Published Purple Book patent expiration.

    in 5 yr 7 mo

  29. Patent 10,874,677 expires

    Published Purple Book patent expiration.

    in 5 yr 10 mo

  30. Patent 9,539,263 expires

    Published Purple Book patent expiration.

    in 6 yr 1 mo

  31. Patent 9,750,752 expires

    Published Purple Book patent expiration.

    in 6 yr 4 mo

  32. Patent 10,590,164 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  33. Patent 9,630,988 expires

    Published Purple Book patent expiration.

    in 7 yr 2 mo

  34. Patent 10,676,710 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  35. Patent 10,829,732 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  36. Patent 10,017,732 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  37. Patent 10,336,983 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

Biosimilars & interchangeables for tocilizumab

3 FDA-licensed follow-on biologics referencing tocilizumab.

Biosimilars and interchangeable biosimilars referencing tocilizumab.
ProductProper nameApplicantTypeBLAApproved
Tofidencetocilizumab-baviBiogen MA Inc.Biosimilar 351(k)761354Sep 29, 2023
Tyennetocilizumab-aazgFresenius Kabi USA, LLCBiosimilar 351(k)761275Mar 05, 2024
Avtozmatocilizumab-anohCELLTRION, Inc.Biosimilar 351(k)761498Jan 24, 2025

Published patents

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

Published Purple Book patents for tocilizumab.
PatentExpiresIn
7,332,289Aug 04, 20232 yr 10 mo ago
10,744,201Apr 28, 20242 yr 1 mo ago
7,521,052Apr 28, 20242 yr 1 mo ago
8,709,409Jun 22, 20242 yr ago
8,734,800Mar 24, 20251 yr 2 mo ago
9,902,777May 28, 20251 yr ago
8,617,550Mar 03, 20263 mo ago
8,398,980Feb 25, 2028in 1 yr 9 mo
11,078,294Jul 08, 2028in 2 yr 2 mo
8,574,869Jul 08, 2028in 2 yr 2 mo
11,008,394Dec 26, 2028in 2 yr 7 mo
11,359,026Dec 26, 2028in 2 yr 7 mo
11,584,798Dec 26, 2028in 2 yr 7 mo
11,136,375Jul 19, 2029in 3 yr 2 mo
8,568,720Nov 05, 2029in 3 yr 6 mo
10,982,003Aug 06, 2030in 4 yr 3 mo
9,714,293Aug 06, 2030in 4 yr 3 mo
10,501,769Oct 25, 2030in 4 yr 6 mo
11,021,728Oct 25, 2030in 4 yr 6 mo
11,136,610Oct 25, 2030in 4 yr 6 mo
11,377,678Oct 25, 2030in 4 yr 6 mo
8,512,983Jan 04, 2031in 4 yr 8 mo
10,662,237Aug 07, 2031in 5 yr 3 mo
11,667,720Nov 07, 2031in 5 yr 6 mo
8,580,264Nov 07, 2031in 5 yr 6 mo
10,231,981Dec 03, 2031in 5 yr 7 mo
10,874,677Mar 02, 2032in 5 yr 10 mo
9,539,263May 23, 2032in 6 yr 1 mo
9,750,752Aug 30, 2032in 6 yr 4 mo
10,590,164Mar 19, 2033in 6 yr 11 mo
9,630,988Jun 13, 2033in 7 yr 2 mo
10,676,710Mar 14, 2034in 7 yr 11 mo
10,829,732Mar 14, 2034in 7 yr 11 mo
10,017,732Dec 25, 2034in 8 yr 8 mo
10,336,983Jul 31, 2035in 9 yr 4 mo

Frequently asked questions

What biosimilars are approved for tocilizumab (Actemra)?

The FDA Purple Book lists 3 approved follow-on biologics referencing tocilizumab: Tofidence, Tyenne, and Avtozma. Of these, 0 are interchangeable biosimilars and 3 are 351(k) biosimilars.

Who makes tocilizumab biosimilars?

Companies with FDA-approved follow-on biologics referencing tocilizumab include Biogen MA Inc., Fresenius Kabi USA, LLC, and CELLTRION, Inc..

How many patents are listed for tocilizumab (Actemra) in the Purple Book?

35 patents are published in the FDA Purple Book Patent List for tocilizumab.

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