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Purple Book reference family · 351(a) biologic

adalimumab (Humira)

adalimumab is an FDA-licensed reference biologic from AbbVie Inc., with 10 approved follow-on biologics.

351(a) biologicBLA 125057 AbbVie Inc.
Biosimilars
2
Interchangeables
8
Listed patents
66
Reference approved
2015

Reference product

Originator biologic
351(a)BLA 125057

Humira adalimumab

AbbVie Inc.

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

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for adalimumab from the RCSB Protein Data Bank (PDB 4NYL).

3D molecular structure of adalimumab (PDB entry 4NYL)

Interactive biological assembly from PDB entry 4NYL. 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 4NYL details

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference adalimumab product.

    11 yr ago

  2. Patent 8,911,737 expires

    Published Purple Book patent expiration.

    4 yr 4 mo ago

  3. Patent 8,974,790 expires

    Published Purple Book patent expiration.

    4 yr 4 mo ago

  4. Patent 8,992,926 expires

    Published Purple Book patent expiration.

    4 yr 4 mo ago

  5. Patent 9,546,212 expires

    Published Purple Book patent expiration.

    4 yr 4 mo ago

  6. Patent 6,805,686 expires

    Published Purple Book patent expiration.

    3 yr 5 mo ago

  7. Patent 8,906,373 expires

    Published Purple Book patent expiration.

    3 yr 3 mo ago

  8. Patent 9,067,992 expires

    Published Purple Book patent expiration.

    3 yr 3 mo ago

  9. Patent 9,085,620 expires

    Published Purple Book patent expiration.

    3 yr 3 mo ago

  10. Patent 9,090,689 expires

    Published Purple Book patent expiration.

    3 yr 3 mo ago

  11. Patent 8,961,973 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  12. Patent 8,961,974 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  13. Patent 8,986,693 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  14. Patent 9,061,005 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  15. Patent 9,187,559 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  16. Patent 9,512,216 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  17. Patent 8,808,700 expires

    Published Purple Book patent expiration.

    4 mo ago

  18. Patent 11,083,792 expires

    Published Purple Book patent expiration.

    in 7 mo

  19. Patent 8,231,876 expires

    Published Purple Book patent expiration.

    in 7 mo

  20. Patent 8,883,156 expires

    Published Purple Book patent expiration.

    in 7 mo

  21. Patent 8,895,009 expires

    Published Purple Book patent expiration.

    in 7 mo

  22. Patent 8,906,372 expires

    Published Purple Book patent expiration.

    in 7 mo

  23. Patent 8,916,153 expires

    Published Purple Book patent expiration.

    in 7 mo

  24. Patent 9,096,666 expires

    Published Purple Book patent expiration.

    in 7 mo

  25. Patent 9,102,723 expires

    Published Purple Book patent expiration.

    in 7 mo

  26. Patent 9,273,132 expires

    Published Purple Book patent expiration.

    in 7 mo

  27. Patent 9,328,165 expires

    Published Purple Book patent expiration.

    in 7 mo

  28. Patent 9,913,902 expires

    Published Purple Book patent expiration.

    in 7 mo

  29. Patent 8,926,975 expires

    Published Purple Book patent expiration.

    in 9 mo

  30. Patent 8,715,664 expires

    Published Purple Book patent expiration.

    in 10 mo

  31. Patent 8,663,945 expires

    Published Purple Book patent expiration.

    in 1 yr

  32. Patent 8,906,646 expires

    Published Purple Book patent expiration.

    in 1 yr

  33. Patent 8,911,964 expires

    Published Purple Book patent expiration.

    in 1 yr

  34. Patent 9,090,867 expires

    Published Purple Book patent expiration.

    in 1 yr

  35. Patent 9,234,032 expires

    Published Purple Book patent expiration.

    in 1 yr

  36. Patent 9,284,371 expires

    Published Purple Book patent expiration.

    in 1 yr

  37. Patent 8,889,136 expires

    Published Purple Book patent expiration.

    in 1 yr 1 mo

  38. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 1 yr 5 mo

  39. Patent 9,284,370 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  40. Patent 9,669,093 expires

    Published Purple Book patent expiration.

    in 1 yr 9 mo

  41. Patent 11,167,030 expires

    Published Purple Book patent expiration.

    in 2 yr 3 mo

  42. Patent 11,191,834 expires

    Published Purple Book patent expiration.

    in 2 yr 3 mo

  43. Patent 9,085,619 expires

    Published Purple Book patent expiration.

    in 2 yr 3 mo

  44. Patent 8,420,081 expires

    Published Purple Book patent expiration.

    in 3 yr 4 mo

  45. Patent 8,999,337 expires

    Published Purple Book patent expiration.

    in 4 yr 5 mo

  46. Patent 9,624,295 expires

    Published Purple Book patent expiration.

    in 4 yr 7 mo

  47. Patent 8,708,968 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  48. Patent 9,339,610 expires

    Published Purple Book patent expiration.

    in 5 yr 5 mo

  49. Patent 9,062,106 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  50. Patent 9,090,688 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  51. Patent 9,505,834 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  52. Patent 9,522,953 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  53. Patent 9,683,033 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  54. Patent 9,957,318 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  55. Patent 9,085,618 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  56. Patent 9,181,337 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  57. Patent 9,181,572 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  58. Patent 9,290,568 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  59. Patent 9,334,319 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  60. Patent 9,346,879 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  61. Patent 9,359,434 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  62. Patent 9,499,616 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  63. Patent 9,708,400 expires

    Published Purple Book patent expiration.

    in 6 yr 7 mo

  64. Patent 9,315,574 expires

    Published Purple Book patent expiration.

    in 6 yr 8 mo

  65. Patent 9,150,645 expires

    Published Purple Book patent expiration.

    in 6 yr 9 mo

  66. Patent 9,266,949 expires

    Published Purple Book patent expiration.

    in 6 yr 9 mo

  67. Patent 9,499,614 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  68. Patent 9,550,826 expires

    Published Purple Book patent expiration.

    in 8 yr 3 mo

Biosimilars & interchangeables for adalimumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing adalimumab.
ProductProper nameApplicantTypeBLAApproved
Amjevitaadalimumab-attoAmgen Inc.Interchangeable761024
Abriladaadalimumab-afzbPfizer Inc.Interchangeable761118
Hulioadalimumab-fkjpBiocon Biologics Inc.Interchangeable761154
Cyltezoadalimumab-adbmBoehringer Ingelheim Pharmaceuticals, Inc.Interchangeable761058
Hadlimaadalimumab-bwwdSamsung Bioepis Co., Ltd.Interchangeable761059
Idacioadalimumab-aacfFresenius Kabi USA, LLCBiosimilar 351(k)761255
Yusimryadalimumab-aqvhHong Kong King-Friend Industrial Company LimitedBiosimilar 351(k)761216
Hyrimozadalimumab-adazSandoz Inc.Interchangeable761071
Yuflymaadalimumab-aatyCELLTRION, Inc.Interchangeable761219
Simlandiadalimumab-ryvkAlvotech USA Inc.Interchangeable761299

Published patents

Purple Book patent list
Published Purple Book patents for adalimumab.
PatentExpiresIn
8,911,7374 yr 4 mo ago
8,974,7904 yr 4 mo ago
8,992,9264 yr 4 mo ago
9,546,2124 yr 4 mo ago
6,805,6863 yr 5 mo ago
8,906,3733 yr 3 mo ago
9,067,9923 yr 3 mo ago
9,085,6203 yr 3 mo ago
9,090,6893 yr 3 mo ago
8,961,9731 yr 6 mo ago
8,961,9741 yr 6 mo ago
8,986,6931 yr 6 mo ago
9,061,0051 yr 6 mo ago
9,187,5591 yr 6 mo ago
9,512,2161 yr 6 mo ago
8,808,7004 mo ago
11,083,792in 7 mo
8,231,876in 7 mo
8,883,156in 7 mo
8,895,009in 7 mo
8,906,372in 7 mo
8,916,153in 7 mo
9,096,666in 7 mo
9,102,723in 7 mo
9,273,132in 7 mo
9,328,165in 7 mo
9,913,902in 7 mo
8,926,975in 9 mo
8,715,664in 10 mo
8,663,945in 1 yr
8,906,646in 1 yr
8,911,964in 1 yr
9,090,867in 1 yr
9,234,032in 1 yr
9,284,371in 1 yr
8,889,136in 1 yr 1 mo
9,284,370in 1 yr 9 mo
9,669,093in 1 yr 9 mo
11,167,030in 2 yr 3 mo
11,191,834in 2 yr 3 mo
9,085,619in 2 yr 3 mo
8,420,081in 3 yr 4 mo
8,999,337in 4 yr 5 mo
9,624,295in 4 yr 7 mo
8,708,968in 5 yr 5 mo
9,339,610in 5 yr 5 mo
9,062,106in 5 yr 8 mo
9,090,688in 5 yr 8 mo
9,505,834in 5 yr 8 mo
9,522,953in 5 yr 8 mo
9,683,033in 5 yr 8 mo
9,957,318in 5 yr 8 mo
9,085,618in 6 yr 7 mo
9,181,337in 6 yr 7 mo
9,181,572in 6 yr 7 mo
9,290,568in 6 yr 7 mo
9,334,319in 6 yr 7 mo
9,346,879in 6 yr 7 mo
9,359,434in 6 yr 7 mo
9,499,616in 6 yr 7 mo
9,708,400in 6 yr 7 mo
9,315,574in 6 yr 8 mo
9,150,645in 6 yr 9 mo
9,266,949in 6 yr 9 mo
9,499,614in 7 yr 7 mo
9,550,826in 8 yr 3 mo

adalimumab: 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 adalimumab.

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