Assyro AI

Orange Book product · Brand (NDA)

IMBRUVICA

IBRUTINIB

Brand (NDA)NDA 217003RX PHARMACYCLICS LLC
View IBRUTINIB familyOpen on FDA Orange Book

At a glance

Aug 24, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

86

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 24, 2022

    3 yr 11 mo ago

  2. Exclusivity ends · NP

    New product exclusivity (3 years)

    Aug 24, 2025

    10 mo ago

  3. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Feb 24, 2026

    4 mo ago

  4. Today

  5. Patent 7514444 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  6. Patent 8476284 expires

    Listed method-of-use patent (U-3843) expiration.

    Dec 28, 2026

    in 6 mo

  7. Patent 8476284 expires

    Listed method-of-use patent (U-3844) expiration.

    Dec 28, 2026

    in 6 mo

  8. Patent 8476284 expires

    Listed method-of-use patent (U-3845) expiration.

    Dec 28, 2026

    in 6 mo

  9. Patent 8497277 expires

    Listed method-of-use patent (U-3422) expiration.

    Dec 28, 2026

    in 6 mo

  10. Patent 8497277 expires

    Listed method-of-use patent (U-3842) expiration.

    Dec 28, 2026

    in 6 mo

  11. Patent 8497277 expires

    Listed method-of-use patent (U-3843) expiration.

    Dec 28, 2026

    in 6 mo

  12. Patent 8497277 expires

    Listed method-of-use patent (U-3845) expiration.

    Dec 28, 2026

    in 6 mo

  13. Patent 8497277 expires

    Listed method-of-use patent (U-3844) expiration.

    Dec 28, 2026

    in 6 mo

  14. Patent 8497277 expires

    Listed method-of-use patent (U-2666) expiration.

    Dec 28, 2026

    in 6 mo

  15. Patent 8497277 expires

    Listed method-of-use patent (U-2970) expiration.

    Dec 28, 2026

    in 6 mo

  16. Patent 8697711 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  17. Patent 8703780 expires

    Listed method-of-use patent (U-2666) expiration.

    Dec 28, 2026

    in 6 mo

  18. Patent 8703780 expires

    Listed method-of-use patent (U-3842) expiration.

    Dec 28, 2026

    in 6 mo

  19. Patent 8735403 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  20. Patent 8754091 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  21. Patent 8952015 expires

    Listed method-of-use patent (U-2666) expiration.

    Dec 28, 2026

    in 6 mo

  22. Patent 8952015 expires

    Listed method-of-use patent (U-3842) expiration.

    Dec 28, 2026

    in 6 mo

  23. Patent 8952015 expires

    Listed method-of-use patent (U-3843) expiration.

    Dec 28, 2026

    in 6 mo

  24. Patent 8952015 expires

    Listed method-of-use patent (U-3844) expiration.

    Dec 28, 2026

    in 6 mo

  25. Patent 8952015 expires

    Listed method-of-use patent (U-3845) expiration.

    Dec 28, 2026

    in 6 mo

  26. Patent 8957079 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  27. Patent 9181257 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  28. Patent 8563563 expires

    Listed method-of-use patent (U-3844) expiration.

    Apr 26, 2027

    in 10 mo

  29. Patent 8563563 expires

    Listed method-of-use patent (U-3843) expiration.

    Apr 26, 2027

    in 10 mo

  30. Patent 8563563 expires

    Listed method-of-use patent (U-3842) expiration.

    Apr 26, 2027

    in 10 mo

  31. Patent 8563563 expires

    Listed method-of-use patent (U-2666) expiration.

    Apr 26, 2027

    in 10 mo

  32. Patent 8563563 expires

    Listed method-of-use patent (U-3845) expiration.

    Apr 26, 2027

    in 10 mo

  33. Patent 7514444*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  34. Patent 8497277*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  35. Patent 8697711*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  36. Patent 8735403*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  37. Patent 8754091*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  38. Patent 8957079*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  39. Patent 9181257*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  40. Patent 8008309 expires

    Listed drug substance patent expiration.

    Nov 13, 2027

    in 1 yr 5 mo

  41. Patent 8008309*PED expires

    Listed listed patent expiration.

    May 13, 2028

    in 1 yr 11 mo

  42. Exclusivity ends · ODE-405

    Orphan-drug exclusivity (7 years)

    Aug 24, 2029

    in 3 yr 3 mo

  43. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Feb 24, 2030

    in 3 yr 9 mo

  44. Patent 10004746 expires

    Listed method-of-use patent (U-3846) expiration.

    Jun 03, 2031

    in 5 yr

  45. Patent 10004746 expires

    Listed method-of-use patent (U-3848) expiration.

    Jun 03, 2031

    in 5 yr

  46. Patent 10004746 expires

    Listed method-of-use patent (U-3849) expiration.

    Jun 03, 2031

    in 5 yr

  47. Patent 10004746 expires

    Listed method-of-use patent (U-3847) expiration.

    Jun 03, 2031

    in 5 yr

  48. Patent 10016435 expires

    Listed method-of-use patent (U-3845) expiration.

    Jun 03, 2031

    in 5 yr

  49. Patent 10478439 expires

    Listed method-of-use patent (U-3422) expiration.

    Jun 03, 2031

    in 5 yr

  50. Patent 10478439 expires

    Listed method-of-use patent (U-3842) expiration.

    Jun 03, 2031

    in 5 yr

  51. Patent 10478439 expires

    Listed method-of-use patent (U-3844) expiration.

    Jun 03, 2031

    in 5 yr

  52. Patent 10478439 expires

    Listed method-of-use patent (U-2666) expiration.

    Jun 03, 2031

    in 5 yr

  53. Patent 10478439 expires

    Listed method-of-use patent (U-2970) expiration.

    Jun 03, 2031

    in 5 yr

  54. Patent 10478439 expires

    Listed method-of-use patent (U-3843) expiration.

    Jun 03, 2031

    in 5 yr

  55. Patent 10478439 expires

    Listed method-of-use patent (U-3845) expiration.

    Jun 03, 2031

    in 5 yr

  56. Patent 10751342 expires

    Listed method-of-use patent (U-2666) expiration.

    Jun 03, 2031

    in 5 yr

  57. Patent 10751342 expires

    Listed method-of-use patent (U-3844) expiration.

    Jun 03, 2031

    in 5 yr

  58. Patent 10751342 expires

    Listed method-of-use patent (U-3843) expiration.

    Jun 03, 2031

    in 5 yr

  59. Patent 10751342 expires

    Listed method-of-use patent (U-3842) expiration.

    Jun 03, 2031

    in 5 yr

  60. Patent 11672803 expires

    Listed method-of-use patent (U-2666) expiration.

    Jun 03, 2031

    in 5 yr

  61. Patent 11672803 expires

    Listed method-of-use patent (U-3842) expiration.

    Jun 03, 2031

    in 5 yr

  62. Patent 11672803 expires

    Listed method-of-use patent (U-3844) expiration.

    Jun 03, 2031

    in 5 yr

  63. Patent 11672803 expires

    Listed method-of-use patent (U-3843) expiration.

    Jun 03, 2031

    in 5 yr

  64. Patent 8999999 expires

    Listed method-of-use patent (U-2666) expiration.

    Jun 03, 2031

    in 5 yr

  65. Patent 8999999 expires

    Listed method-of-use patent (U-3842) expiration.

    Jun 03, 2031

    in 5 yr

  66. Patent 8999999 expires

    Listed method-of-use patent (U-3843) expiration.

    Jun 03, 2031

    in 5 yr

  67. Patent 8999999 expires

    Listed method-of-use patent (U-3844) expiration.

    Jun 03, 2031

    in 5 yr

  68. Patent 9125889 expires

    Listed method-of-use patent (U-3845) expiration.

    Jun 03, 2031

    in 5 yr

  69. Patent 9801881 expires

    Listed method-of-use patent (U-3846) expiration.

    Jun 03, 2031

    in 5 yr

  70. Patent 9801881 expires

    Listed method-of-use patent (U-3847) expiration.

    Jun 03, 2031

    in 5 yr

  71. Patent 9801883 expires

    Listed method-of-use patent (U-2666) expiration.

    Jun 03, 2031

    in 5 yr

  72. Patent 9801883 expires

    Listed method-of-use patent (U-3842) expiration.

    Jun 03, 2031

    in 5 yr

  73. Patent 9801883 expires

    Listed method-of-use patent (U-3843) expiration.

    Jun 03, 2031

    in 5 yr

  74. Patent 9801883 expires

    Listed method-of-use patent (U-3844) expiration.

    Jun 03, 2031

    in 5 yr

  75. Patent 10478439*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  76. Patent 10106548 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  77. Patent 10125140 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  78. Patent 10961251 expires

    Listed drug product patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  79. Patent 9725455 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  80. Patent 9296753 expires

    Listed drug substance patent expiration.

    Oct 30, 2033

    in 7 yr 6 mo

  81. Patent 10106548*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  82. Patent 10125140*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  83. Patent 10961251*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  84. Patent 9725455*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  85. Patent 9296753*PED expires

    Listed listed patent expiration.

    Apr 30, 2034

    in 8 yr

  86. Patent 10463668 expires

    Listed method-of-use patent (U-2970) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  87. Patent 10695350 expires

    Listed method-of-use patent (U-2970) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  88. Patent 9795604 expires

    Listed method-of-use patent (U-3422) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  89. Patent 9795604 expires

    Listed method-of-use patent (U-2970) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  90. Patent 9795604*PED expires

    Listed listed patent expiration.

    Apr 24, 2035

    in 9 yr

  91. Patent 12364698 expires

    Listed drug product patent expiration.

    Apr 06, 2036

    in 9 yr 11 mo

  92. Patent 12201690 expires

    Listed drug product patent expiration.

    Jun 14, 2039

    in 13 yr 2 mo

Pharmaceutical detail

Active ingredient

IBRUTINIB

Strength

70MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 217003

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (4)

  • NPNew product exclusivity (3 years)

    Aug 24, 2025

    10 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Feb 24, 2026

    4 mo ago

  • ODE-405Orphan-drug exclusivity (7 years)

    Aug 24, 2029

    in 3 yr 3 mo

  • PEDPediatric exclusivity (adds 6 months)

    Feb 24, 2030

    in 3 yr 9 mo

Listed patents (86)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7514444Dec 28, 2026in 6 mo
SubstanceProduct
8476284Dec 28, 2026in 6 mo
U-3843
8476284Dec 28, 2026in 6 mo
U-3844
8476284Dec 28, 2026in 6 mo
U-3845
8497277Dec 28, 2026in 6 mo
U-3422
8497277Dec 28, 2026in 6 mo
U-3842
8497277Dec 28, 2026in 6 mo
U-3843
8497277Dec 28, 2026in 6 mo
U-3845
8497277Dec 28, 2026in 6 mo
U-3844
8497277Dec 28, 2026in 6 mo
U-2666
8497277Dec 28, 2026in 6 mo
U-2970
8697711Dec 28, 2026in 6 mo
SubstanceProduct
8703780Dec 28, 2026in 6 mo
U-2666
8703780Dec 28, 2026in 6 mo
U-3842
8735403Dec 28, 2026in 6 mo
SubstanceProduct
8754091Dec 28, 2026in 6 mo
Product
8952015Dec 28, 2026in 6 mo
U-2666
8952015Dec 28, 2026in 6 mo
U-3842
8952015Dec 28, 2026in 6 mo
U-3843
8952015Dec 28, 2026in 6 mo
U-3844
8952015Dec 28, 2026in 6 mo
U-3845
8957079Dec 28, 2026in 6 mo
SubstanceProduct
9181257Dec 28, 2026in 6 mo
Substance
8563563Apr 26, 2027in 10 mo
U-3844
8563563Apr 26, 2027in 10 mo
U-3843
8563563Apr 26, 2027in 10 mo
U-3842
8563563Apr 26, 2027in 10 mo
U-2666
8563563Apr 26, 2027in 10 mo
U-3845
7514444*PEDJun 28, 2027in 1 yr
8497277*PEDJun 28, 2027in 1 yr
8697711*PEDJun 28, 2027in 1 yr
8735403*PEDJun 28, 2027in 1 yr
8754091*PEDJun 28, 2027in 1 yr
8957079*PEDJun 28, 2027in 1 yr
9181257*PEDJun 28, 2027in 1 yr
8008309Nov 13, 2027in 1 yr 5 mo
SubstanceProduct
8008309*PEDMay 13, 2028in 1 yr 11 mo
10004746Jun 03, 2031in 5 yr
U-3846
10004746Jun 03, 2031in 5 yr
U-3848
10004746Jun 03, 2031in 5 yr
U-3849
10004746Jun 03, 2031in 5 yr
U-3847
10016435Jun 03, 2031in 5 yr
U-3845
10478439Jun 03, 2031in 5 yr
U-3422
10478439Jun 03, 2031in 5 yr
U-3842
10478439Jun 03, 2031in 5 yr
U-3844
10478439Jun 03, 2031in 5 yr
U-2666
10478439Jun 03, 2031in 5 yr
U-2970
10478439Jun 03, 2031in 5 yr
U-3843
10478439Jun 03, 2031in 5 yr
U-3845
10751342Jun 03, 2031in 5 yr
U-2666
10751342Jun 03, 2031in 5 yr
U-3844
10751342Jun 03, 2031in 5 yr
U-3843
10751342Jun 03, 2031in 5 yr
U-3842
11672803Jun 03, 2031in 5 yr
U-2666
11672803Jun 03, 2031in 5 yr
U-3842
11672803Jun 03, 2031in 5 yr
U-3844
11672803Jun 03, 2031in 5 yr
U-3843
8999999Jun 03, 2031in 5 yr
U-2666
8999999Jun 03, 2031in 5 yr
U-3842
8999999Jun 03, 2031in 5 yr
U-3843
8999999Jun 03, 2031in 5 yr
U-3844
9125889Jun 03, 2031in 5 yr
U-3845
9801881Jun 03, 2031in 5 yr
U-3846
9801881Jun 03, 2031in 5 yr
U-3847
9801883Jun 03, 2031in 5 yr
U-2666
9801883Jun 03, 2031in 5 yr
U-3842
9801883Jun 03, 2031in 5 yr
U-3843
9801883Jun 03, 2031in 5 yr
U-3844
10478439*PEDDec 03, 2031in 5 yr 6 mo
10106548Jun 03, 2033in 7 yr 1 mo
SubstanceProduct
10125140Jun 03, 2033in 7 yr 1 mo
SubstanceProduct
10961251Jun 03, 2033in 7 yr 1 mo
Product
9725455Jun 03, 2033in 7 yr 1 mo
Substance
9296753Oct 30, 2033in 7 yr 6 mo
Substance
10106548*PEDDec 03, 2033in 7 yr 7 mo
10125140*PEDDec 03, 2033in 7 yr 7 mo
10961251*PEDDec 03, 2033in 7 yr 7 mo
9725455*PEDDec 03, 2033in 7 yr 7 mo
9296753*PEDApr 30, 2034in 8 yr
10463668Oct 24, 2034in 8 yr 6 mo
U-2970
10695350Oct 24, 2034in 8 yr 6 mo
U-2970
9795604Oct 24, 2034in 8 yr 6 mo
U-3422
9795604Oct 24, 2034in 8 yr 6 mo
U-2970
9795604*PEDApr 24, 2035in 9 yr
12364698Apr 06, 2036in 9 yr 11 mo
Product
12201690Jun 14, 2039in 13 yr 2 mo
Product
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