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FDA Purple Book · Reference family

adalimumab (Humira)

adalimumab is an FDA-licensed reference biologic from AbbVie Inc., with 10 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

2

Biosimilars

8

Interchangeables

66

Listed patents

2015

Reference approved

Reference product

351(a)BLA 125057

Humira adalimumab

AbbVie Inc.

Approved
Nov 23, 2015
Marketing
Rx
Center
CDER
Patents
66 listed

Molecular structure

Experimental 3D structure for adalimumab from the RCSB Protein Data Bank (PDB 8XJ0).

3D molecular structure of adalimumab (PDB entry 8XJ0)

Interactive biological assembly from PDB entry 8XJ0. 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 8XJ0 details

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference adalimumab product.

    10 yr 8 mo ago

  2. Patent 8,911,737 expires

    Published Purple Book patent expiration.

    4 yr 1 mo ago

  3. Patent 8,974,790 expires

    Published Purple Book patent expiration.

    4 yr 1 mo ago

  4. Patent 8,992,926 expires

    Published Purple Book patent expiration.

    4 yr 1 mo ago

  5. Patent 9,546,212 expires

    Published Purple Book patent expiration.

    4 yr 1 mo ago

  6. Patent 6,805,686 expires

    Published Purple Book patent expiration.

    3 yr 1 mo ago

  7. Patent 8,906,373 expires

    Published Purple Book patent expiration.

    2 yr 11 mo ago

  8. Patent 9,067,992 expires

    Published Purple Book patent expiration.

    2 yr 11 mo ago

  9. Patent 9,085,620 expires

    Published Purple Book patent expiration.

    2 yr 11 mo ago

  10. Patent 9,090,689 expires

    Published Purple Book patent expiration.

    2 yr 11 mo ago

  11. Patent 8,961,973 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  12. Patent 8,961,974 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  13. Patent 8,986,693 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  14. Patent 9,061,005 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  15. Patent 9,187,559 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  16. Patent 9,512,216 expires

    Published Purple Book patent expiration.

    1 yr 2 mo ago

  17. Patent 8,808,700 expires

    Published Purple Book patent expiration.

    16 d ago

  18. Patent 11,083,792 expires

    Published Purple Book patent expiration.

    in 10 mo

  19. Patent 8,231,876 expires

    Published Purple Book patent expiration.

    in 10 mo

  20. Patent 8,883,156 expires

    Published Purple Book patent expiration.

    in 10 mo

  21. Patent 8,895,009 expires

    Published Purple Book patent expiration.

    in 10 mo

  22. Patent 8,906,372 expires

    Published Purple Book patent expiration.

    in 10 mo

  23. Patent 8,916,153 expires

    Published Purple Book patent expiration.

    in 10 mo

  24. Patent 9,096,666 expires

    Published Purple Book patent expiration.

    in 10 mo

  25. Patent 9,102,723 expires

    Published Purple Book patent expiration.

    in 10 mo

  26. Patent 9,273,132 expires

    Published Purple Book patent expiration.

    in 10 mo

  27. Patent 9,328,165 expires

    Published Purple Book patent expiration.

    in 10 mo

  28. Patent 9,913,902 expires

    Published Purple Book patent expiration.

    in 10 mo

  29. Patent 8,926,975 expires

    Published Purple Book patent expiration.

    in 1 yr

  30. Patent 8,715,664 expires

    Published Purple Book patent expiration.

    in 1 yr 2 mo

  31. Patent 8,663,945 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  32. Patent 8,906,646 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  33. Patent 8,911,964 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  34. Patent 9,090,867 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  35. Patent 9,234,032 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  36. Patent 9,284,371 expires

    Published Purple Book patent expiration.

    in 1 yr 4 mo

  37. Patent 8,889,136 expires

    Published Purple Book patent expiration.

    in 1 yr 5 mo

  38. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr 9 mo

  39. Patent 9,284,370 expires

    Published Purple Book patent expiration.

    in 2 yr 1 mo

  40. Patent 9,669,093 expires

    Published Purple Book patent expiration.

    in 2 yr 1 mo

  41. Patent 11,167,030 expires

    Published Purple Book patent expiration.

    in 2 yr 6 mo

  42. Patent 11,191,834 expires

    Published Purple Book patent expiration.

    in 2 yr 6 mo

  43. Patent 9,085,619 expires

    Published Purple Book patent expiration.

    in 2 yr 6 mo

  44. Patent 8,420,081 expires

    Published Purple Book patent expiration.

    in 3 yr 8 mo

  45. Patent 8,999,337 expires

    Published Purple Book patent expiration.

    in 4 yr 9 mo

  46. Patent 9,624,295 expires

    Published Purple Book patent expiration.

    in 4 yr 11 mo

  47. Patent 8,708,968 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  48. Patent 9,339,610 expires

    Published Purple Book patent expiration.

    in 5 yr 9 mo

  49. Patent 9,062,106 expires

    Published Purple Book patent expiration.

    in 6 yr

  50. Patent 9,090,688 expires

    Published Purple Book patent expiration.

    in 6 yr

  51. Patent 9,505,834 expires

    Published Purple Book patent expiration.

    in 6 yr

  52. Patent 9,522,953 expires

    Published Purple Book patent expiration.

    in 6 yr

  53. Patent 9,683,033 expires

    Published Purple Book patent expiration.

    in 6 yr

  54. Patent 9,957,318 expires

    Published Purple Book patent expiration.

    in 6 yr

  55. Patent 9,085,618 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  56. Patent 9,181,337 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  57. Patent 9,181,572 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  58. Patent 9,290,568 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  59. Patent 9,334,319 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  60. Patent 9,346,879 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  61. Patent 9,359,434 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  62. Patent 9,499,616 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  63. Patent 9,708,400 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  64. Patent 9,315,574 expires

    Published Purple Book patent expiration.

    in 7 yr

  65. Patent 9,150,645 expires

    Published Purple Book patent expiration.

    in 7 yr 1 mo

  66. Patent 9,266,949 expires

    Published Purple Book patent expiration.

    in 7 yr 1 mo

  67. Patent 9,499,614 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  68. Patent 9,550,826 expires

    Published Purple Book patent expiration.

    in 8 yr 7 mo

Biosimilars & interchangeables for adalimumab

10 FDA-licensed follow-on biologics referencing adalimumab.

Biosimilars and interchangeable biosimilars referencing adalimumab.
ProductProper nameApplicantTypeBLAApproved
Amjevitaadalimumab-attoAmgen Inc.Interchangeable761024Sep 23, 2016
Abriladaadalimumab-afzbPfizer Inc.Interchangeable761118Nov 15, 2019
Hulioadalimumab-fkjpBiocon Biologics Inc.Interchangeable761154Jul 06, 2020
Cyltezoadalimumab-adbmBoehringer Ingelheim Pharmaceuticals, Inc.Interchangeable761058Mar 18, 2022
Hadlimaadalimumab-bwwdSamsung Bioepis Co., Ltd.Interchangeable761059Aug 15, 2022
Idacioadalimumab-aacfFresenius Kabi USA, LLCBiosimilar 351(k)761255Dec 13, 2022
Yusimryadalimumab-aqvhHong Kong King-Friend Industrial Company LimitedBiosimilar 351(k)761216Feb 27, 2023
Hyrimozadalimumab-adazSandoz Inc.Interchangeable761071Mar 20, 2023
Yuflymaadalimumab-aatyCELLTRION, Inc.Interchangeable761219May 23, 2023
Simlandiadalimumab-ryvkAlvotech USA Inc.Interchangeable761299Jun 26, 2024

Published patents

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

Published Purple Book patents for adalimumab.
PatentExpiresIn
8,911,737Jun 05, 20224 yr 1 mo ago
8,974,790Jun 05, 20224 yr 1 mo ago
8,992,926Jun 05, 20224 yr 1 mo ago
9,546,212Jun 05, 20224 yr 1 mo ago
6,805,686May 06, 20233 yr 1 mo ago
8,906,373Jul 18, 20232 yr 11 mo ago
9,067,992Jul 18, 20232 yr 11 mo ago
9,085,620Jul 18, 20232 yr 11 mo ago
9,090,689Jul 18, 20232 yr 11 mo ago
8,961,973Apr 11, 20251 yr 2 mo ago
8,961,974Apr 11, 20251 yr 2 mo ago
8,986,693Apr 11, 20251 yr 2 mo ago
9,061,005Apr 11, 20251 yr 2 mo ago
9,187,559Apr 11, 20251 yr 2 mo ago
9,512,216Apr 11, 20251 yr 2 mo ago
8,808,700May 16, 202616 d ago
11,083,792Apr 04, 2027in 10 mo
8,231,876Apr 04, 2027in 10 mo
8,883,156Apr 04, 2027in 10 mo
8,895,009Apr 04, 2027in 10 mo
8,906,372Apr 04, 2027in 10 mo
8,916,153Apr 04, 2027in 10 mo
9,096,666Apr 04, 2027in 10 mo
9,102,723Apr 04, 2027in 10 mo
9,273,132Apr 04, 2027in 10 mo
9,328,165Apr 04, 2027in 10 mo
9,913,902Apr 04, 2027in 10 mo
8,926,975Jun 08, 2027in 1 yr
8,715,664Jul 24, 2027in 1 yr 2 mo
8,663,945Sep 13, 2027in 1 yr 4 mo
8,906,646Sep 13, 2027in 1 yr 4 mo
8,911,964Sep 13, 2027in 1 yr 4 mo
9,090,867Sep 13, 2027in 1 yr 4 mo
9,234,032Sep 13, 2027in 1 yr 4 mo
9,284,371Sep 13, 2027in 1 yr 4 mo
8,889,136Oct 09, 2027in 1 yr 5 mo
9,284,370Jun 10, 2028in 2 yr 1 mo
9,669,093Jun 10, 2028in 2 yr 1 mo
11,167,030Nov 28, 2028in 2 yr 6 mo
11,191,834Nov 28, 2028in 2 yr 6 mo
9,085,619Nov 28, 2028in 2 yr 6 mo
8,420,081Jan 13, 2030in 3 yr 8 mo
8,999,337Feb 06, 2031in 4 yr 9 mo
9,624,295Mar 31, 2031in 4 yr 11 mo
8,708,968Jan 24, 2032in 5 yr 9 mo
9,339,610Jan 24, 2032in 5 yr 9 mo
9,062,106Apr 26, 2032in 6 yr
9,090,688Apr 26, 2032in 6 yr
9,505,834Apr 26, 2032in 6 yr
9,522,953Apr 26, 2032in 6 yr
9,683,033Apr 26, 2032in 6 yr
9,957,318Apr 26, 2032in 6 yr
9,085,618Mar 14, 2033in 6 yr 11 mo
9,181,337Mar 14, 2033in 6 yr 11 mo
9,181,572Mar 14, 2033in 6 yr 11 mo
9,290,568Mar 14, 2033in 6 yr 11 mo
9,334,319Mar 14, 2033in 6 yr 11 mo
9,346,879Mar 14, 2033in 6 yr 11 mo
9,359,434Mar 14, 2033in 6 yr 11 mo
9,499,616Mar 14, 2033in 6 yr 11 mo
9,708,400Mar 14, 2033in 6 yr 11 mo
9,315,574Apr 21, 2033in 7 yr
9,150,645May 13, 2033in 7 yr 1 mo
9,266,949May 13, 2033in 7 yr 1 mo
9,499,614Mar 14, 2034in 7 yr 11 mo
9,550,826Nov 14, 2034in 8 yr 7 mo

Frequently asked questions

What biosimilars are approved for adalimumab (Humira)?

The FDA Purple Book lists 10 approved follow-on biologics referencing adalimumab: Amjevita, Abrilada, Hulio, Cyltezo, Hadlima, Idacio, Yusimry, Hyrimoz, Yuflyma, and Simlandi. Of these, 8 are interchangeable biosimilars and 2 are 351(k) biosimilars.

Is there an interchangeable biosimilar for adalimumab?

Yes. Amjevita, Abrilada, Hulio, Cyltezo, Hadlima, Hyrimoz, Yuflyma, and Simlandi are approved as interchangeable biosimilars for adalimumab, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Who makes adalimumab biosimilars?

Companies with FDA-approved follow-on biologics referencing adalimumab include Amgen Inc., Pfizer Inc., Biocon Biologics Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Samsung Bioepis Co., Ltd., Fresenius Kabi USA, LLC, Hong Kong King-Friend Industrial Company Limited, Sandoz Inc., CELLTRION, Inc., and Alvotech USA Inc..

How many patents are listed for adalimumab (Humira) in the Purple Book?

66 patents are published in the FDA Purple Book Patent List for adalimumab.

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