Assyro AI

Orange Book product · Brand (NDA)

IMBRUVICA

IBRUTINIB

Brand (NDA)NDA 210563RX PHARMACYCLICS LLC
View IBRUTINIB familyOpen on FDA Orange Book

At a glance

Feb 16, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

106

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 16, 2018

    8 yr 6 mo ago

  2. Exclusivity ends · NPP

    New patient population 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-1946) expiration.

    Dec 28, 2026

    in 6 mo

  7. Patent 8476284 expires

    Listed method-of-use patent (U-1650) expiration.

    Dec 28, 2026

    in 6 mo

  8. Patent 8476284 expires

    Listed method-of-use patent (U-2241) expiration.

    Dec 28, 2026

    in 6 mo

  9. Patent 8497277 expires

    Listed method-of-use patent (U-2242) expiration.

    Dec 28, 2026

    in 6 mo

  10. Patent 8497277 expires

    Listed method-of-use patent (U-1650) expiration.

    Dec 28, 2026

    in 6 mo

  11. Patent 8497277 expires

    Listed method-of-use patent (U-2241) expiration.

    Dec 28, 2026

    in 6 mo

  12. Patent 8497277 expires

    Listed method-of-use patent (U-1946) expiration.

    Dec 28, 2026

    in 6 mo

  13. Patent 8497277 expires

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

    Dec 28, 2026

    in 6 mo

  14. Patent 8497277 expires

    Listed method-of-use patent (U-1491) expiration.

    Dec 28, 2026

    in 6 mo

  15. Patent 8697711 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  16. Patent 8703780 expires

    Listed method-of-use patent (U-1491) expiration.

    Dec 28, 2026

    in 6 mo

  17. Patent 8703780 expires

    Listed method-of-use patent (U-2242) expiration.

    Dec 28, 2026

    in 6 mo

  18. Patent 8735403 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  19. Patent 8754091 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  20. Patent 8952015 expires

    Listed method-of-use patent (U-1491) expiration.

    Dec 28, 2026

    in 6 mo

  21. Patent 8952015 expires

    Listed method-of-use patent (U-2241) expiration.

    Dec 28, 2026

    in 6 mo

  22. Patent 8952015 expires

    Listed method-of-use patent (U-2242) expiration.

    Dec 28, 2026

    in 6 mo

  23. Patent 8952015 expires

    Listed method-of-use patent (U-1650) expiration.

    Dec 28, 2026

    in 6 mo

  24. Patent 8952015 expires

    Listed method-of-use patent (U-1946) expiration.

    Dec 28, 2026

    in 6 mo

  25. Patent 8957079 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  26. Patent 9181257 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  27. Patent 8563563 expires

    Listed method-of-use patent (U-1650) expiration.

    Apr 26, 2027

    in 10 mo

  28. Patent 8563563 expires

    Listed method-of-use patent (U-1946) expiration.

    Apr 26, 2027

    in 10 mo

  29. Patent 8563563 expires

    Listed method-of-use patent (U-2242) expiration.

    Apr 26, 2027

    in 10 mo

  30. Patent 8563563 expires

    Listed method-of-use patent (U-2241) expiration.

    Apr 26, 2027

    in 10 mo

  31. Patent 8563563 expires

    Listed method-of-use patent (U-1491) expiration.

    Apr 26, 2027

    in 10 mo

  32. Patent 7514444*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  33. Patent 8476284*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 8703780*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  37. Patent 8735403*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  38. Patent 8754091*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  39. Patent 8952015*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  40. Patent 8957079*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  41. Patent 9181257*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

  42. Patent 8563563*PED expires

    Listed listed patent expiration.

    Oct 26, 2027

    in 1 yr 4 mo

  43. Patent 8008309 expires

    Listed drug substance patent expiration.

    Nov 13, 2027

    in 1 yr 5 mo

  44. Patent 8008309*PED expires

    Listed listed patent expiration.

    May 13, 2028

    in 1 yr 11 mo

  45. Exclusivity ends · ODE-405

    Orphan-drug exclusivity (7 years)

    Aug 24, 2029

    in 3 yr 3 mo

  46. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Feb 24, 2030

    in 3 yr 9 mo

  47. Patent 10004746 expires

    Listed method-of-use patent (U-1946) expiration.

    Jun 03, 2031

    in 5 yr

  48. Patent 10004746 expires

    Listed method-of-use patent (U-2242) expiration.

    Jun 03, 2031

    in 5 yr

  49. Patent 10004746 expires

    Listed method-of-use patent (U-1684) expiration.

    Jun 03, 2031

    in 5 yr

  50. Patent 10004746 expires

    Listed method-of-use patent (U-2241) expiration.

    Jun 03, 2031

    in 5 yr

  51. Patent 10016435 expires

    Listed method-of-use patent (U-1650) expiration.

    Jun 03, 2031

    in 5 yr

  52. Patent 10478439 expires

    Listed method-of-use patent (U-2242) expiration.

    Jun 03, 2031

    in 5 yr

  53. Patent 10478439 expires

    Listed method-of-use patent (U-1650) expiration.

    Jun 03, 2031

    in 5 yr

  54. Patent 10478439 expires

    Listed method-of-use patent (U-1946) expiration.

    Jun 03, 2031

    in 5 yr

  55. Patent 10478439 expires

    Listed method-of-use patent (U-2665) expiration.

    Jun 03, 2031

    in 5 yr

  56. Patent 10478439 expires

    Listed method-of-use patent (U-2241) expiration.

    Jun 03, 2031

    in 5 yr

  57. Patent 10478439 expires

    Listed method-of-use patent (U-1684) expiration.

    Jun 03, 2031

    in 5 yr

  58. Patent 10478439 expires

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

    Jun 03, 2031

    in 5 yr

  59. Patent 10751342 expires

    Listed method-of-use patent (U-1491) expiration.

    Jun 03, 2031

    in 5 yr

  60. Patent 10751342 expires

    Listed method-of-use patent (U-2944) expiration.

    Jun 03, 2031

    in 5 yr

  61. Patent 10751342 expires

    Listed method-of-use patent (U-1946) expiration.

    Jun 03, 2031

    in 5 yr

  62. Patent 10751342 expires

    Listed method-of-use patent (U-2943) expiration.

    Jun 03, 2031

    in 5 yr

  63. Patent 11672803 expires

    Listed method-of-use patent (U-1684) expiration.

    Jun 03, 2031

    in 5 yr

  64. Patent 11672803 expires

    Listed method-of-use patent (U-1946) expiration.

    Jun 03, 2031

    in 5 yr

  65. Patent 11672803 expires

    Listed method-of-use patent (U-2241) expiration.

    Jun 03, 2031

    in 5 yr

  66. Patent 11672803 expires

    Listed method-of-use patent (U-2242) expiration.

    Jun 03, 2031

    in 5 yr

  67. Patent 8999999 expires

    Listed method-of-use patent (U-2241) expiration.

    Jun 03, 2031

    in 5 yr

  68. Patent 8999999 expires

    Listed method-of-use patent (U-1491) expiration.

    Jun 03, 2031

    in 5 yr

  69. Patent 8999999 expires

    Listed method-of-use patent (U-2242) expiration.

    Jun 03, 2031

    in 5 yr

  70. Patent 8999999 expires

    Listed method-of-use patent (U-1946) expiration.

    Jun 03, 2031

    in 5 yr

  71. Patent 9125889 expires

    Listed method-of-use patent (U-1650) expiration.

    Jun 03, 2031

    in 5 yr

  72. Patent 9801881 expires

    Listed method-of-use patent (U-1491) expiration.

    Jun 03, 2031

    in 5 yr

  73. Patent 9801881 expires

    Listed method-of-use patent (U-2242) expiration.

    Jun 03, 2031

    in 5 yr

  74. Patent 9801883 expires

    Listed method-of-use patent (U-2159) expiration.

    Jun 03, 2031

    in 5 yr

  75. Patent 9801883 expires

    Listed method-of-use patent (U-2243) expiration.

    Jun 03, 2031

    in 5 yr

  76. Patent 10004746*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  77. Patent 10016435*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  78. Patent 10478439*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  79. Patent 10751342*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  80. Patent 8999999*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  81. Patent 9125889*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  82. Patent 9801881*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  83. Patent 9801883*PED expires

    Listed listed patent expiration.

    Dec 03, 2031

    in 5 yr 6 mo

  84. Patent 10106548 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  85. Patent 10125140 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  86. Patent 10752634 expires

    Listed drug product patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  87. Patent 10961251 expires

    Listed drug product patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  88. Patent 9725455 expires

    Listed drug substance patent expiration.

    Jun 03, 2033

    in 7 yr 1 mo

  89. Patent 9296753 expires

    Listed drug substance patent expiration.

    Oct 30, 2033

    in 7 yr 6 mo

  90. Patent 10106548*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  91. Patent 10125140*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  92. Patent 10752634*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  93. Patent 10961251*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  94. Patent 9725455*PED expires

    Listed listed patent expiration.

    Dec 03, 2033

    in 7 yr 7 mo

  95. Patent 9296753*PED expires

    Listed listed patent expiration.

    Apr 30, 2034

    in 8 yr

  96. Patent 10463668 expires

    Listed method-of-use patent (U-2654) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  97. Patent 10695350 expires

    Listed method-of-use patent (U-2846) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  98. Patent 9795604 expires

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

    Oct 24, 2034

    in 8 yr 6 mo

  99. Patent 9795604 expires

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

    Oct 24, 2034

    in 8 yr 6 mo

  100. Patent 9795604 expires

    Listed method-of-use patent (U-2969) expiration.

    Oct 24, 2034

    in 8 yr 6 mo

  101. Patent 10463668*PED expires

    Listed listed patent expiration.

    Apr 24, 2035

    in 9 yr

  102. Patent 10695350*PED expires

    Listed listed patent expiration.

    Apr 24, 2035

    in 9 yr

  103. Patent 9795604*PED expires

    Listed listed patent expiration.

    Apr 24, 2035

    in 9 yr

  104. Patent 10010507 expires

    Listed drug product patent expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  105. Patent 10213386 expires

    Listed drug product patent expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  106. Patent 10828259 expires

    Listed drug product patent expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  107. Patent 12551448 expires

    Listed drug product patent expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  108. Patent 9655857 expires

    Listed drug product patent expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  109. Patent 10010507*PED expires

    Listed listed patent expiration.

    Sep 03, 2036

    in 10 yr 4 mo

  110. Patent 10213386*PED expires

    Listed listed patent expiration.

    Sep 03, 2036

    in 10 yr 4 mo

  111. Patent 10828259*PED expires

    Listed listed patent expiration.

    Sep 03, 2036

    in 10 yr 4 mo

  112. Patent 9655857*PED expires

    Listed listed patent expiration.

    Sep 03, 2036

    in 10 yr 4 mo

Pharmaceutical detail

Active ingredient

IBRUTINIB

Strength

140MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210563

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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)

  • NPPNew patient population 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 (106)

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-1946
8476284Dec 28, 2026in 6 mo
U-1650
8476284Dec 28, 2026in 6 mo
U-2241
8497277Dec 28, 2026in 6 mo
U-2242
8497277Dec 28, 2026in 6 mo
U-1650
8497277Dec 28, 2026in 6 mo
U-2241
8497277Dec 28, 2026in 6 mo
U-1946
8497277Dec 28, 2026in 6 mo
U-3422
8497277Dec 28, 2026in 6 mo
U-1491
8697711Dec 28, 2026in 6 mo
SubstanceProduct
8703780Dec 28, 2026in 6 mo
U-1491
8703780Dec 28, 2026in 6 mo
U-2242
8735403Dec 28, 2026in 6 mo
SubstanceProduct
8754091Dec 28, 2026in 6 mo
Product
8952015Dec 28, 2026in 6 mo
U-1491
8952015Dec 28, 2026in 6 mo
U-2241
8952015Dec 28, 2026in 6 mo
U-2242
8952015Dec 28, 2026in 6 mo
U-1650
8952015Dec 28, 2026in 6 mo
U-1946
8957079Dec 28, 2026in 6 mo
SubstanceProduct
9181257Dec 28, 2026in 6 mo
Substance
8563563Apr 26, 2027in 10 mo
U-1650
8563563Apr 26, 2027in 10 mo
U-1946
8563563Apr 26, 2027in 10 mo
U-2242
8563563Apr 26, 2027in 10 mo
U-2241
8563563Apr 26, 2027in 10 mo
U-1491
7514444*PEDJun 28, 2027in 1 yr
8476284*PEDJun 28, 2027in 1 yr
8497277*PEDJun 28, 2027in 1 yr
8697711*PEDJun 28, 2027in 1 yr
8703780*PEDJun 28, 2027in 1 yr
8735403*PEDJun 28, 2027in 1 yr
8754091*PEDJun 28, 2027in 1 yr
8952015*PEDJun 28, 2027in 1 yr
8957079*PEDJun 28, 2027in 1 yr
9181257*PEDJun 28, 2027in 1 yr
8563563*PEDOct 26, 2027in 1 yr 4 mo
8008309Nov 13, 2027in 1 yr 5 mo
SubstanceProduct
8008309*PEDMay 13, 2028in 1 yr 11 mo
10004746Jun 03, 2031in 5 yr
U-1946
10004746Jun 03, 2031in 5 yr
U-2242
10004746Jun 03, 2031in 5 yr
U-1684
10004746Jun 03, 2031in 5 yr
U-2241
10016435Jun 03, 2031in 5 yr
U-1650
10478439Jun 03, 2031in 5 yr
U-2242
10478439Jun 03, 2031in 5 yr
U-1650
10478439Jun 03, 2031in 5 yr
U-1946
10478439Jun 03, 2031in 5 yr
U-2665
10478439Jun 03, 2031in 5 yr
U-2241
10478439Jun 03, 2031in 5 yr
U-1684
10478439Jun 03, 2031in 5 yr
U-3422
10751342Jun 03, 2031in 5 yr
U-1491
10751342Jun 03, 2031in 5 yr
U-2944
10751342Jun 03, 2031in 5 yr
U-1946
10751342Jun 03, 2031in 5 yr
U-2943
11672803Jun 03, 2031in 5 yr
U-1684
11672803Jun 03, 2031in 5 yr
U-1946
11672803Jun 03, 2031in 5 yr
U-2241
11672803Jun 03, 2031in 5 yr
U-2242
8999999Jun 03, 2031in 5 yr
U-2241
8999999Jun 03, 2031in 5 yr
U-1491
8999999Jun 03, 2031in 5 yr
U-2242
8999999Jun 03, 2031in 5 yr
U-1946
9125889Jun 03, 2031in 5 yr
U-1650
9801881Jun 03, 2031in 5 yr
U-1491
9801881Jun 03, 2031in 5 yr
U-2242
9801883Jun 03, 2031in 5 yr
U-2159
9801883Jun 03, 2031in 5 yr
U-2243
10004746*PEDDec 03, 2031in 5 yr 6 mo
10016435*PEDDec 03, 2031in 5 yr 6 mo
10478439*PEDDec 03, 2031in 5 yr 6 mo
10751342*PEDDec 03, 2031in 5 yr 6 mo
8999999*PEDDec 03, 2031in 5 yr 6 mo
9125889*PEDDec 03, 2031in 5 yr 6 mo
9801881*PEDDec 03, 2031in 5 yr 6 mo
9801883*PEDDec 03, 2031in 5 yr 6 mo
10106548Jun 03, 2033in 7 yr 1 mo
SubstanceProduct
10125140Jun 03, 2033in 7 yr 1 mo
SubstanceProduct
10752634Jun 03, 2033in 7 yr 1 mo
Product
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
10752634*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-2654
10695350Oct 24, 2034in 8 yr 6 mo
U-2846
9795604Oct 24, 2034in 8 yr 6 mo
U-3422
9795604Oct 24, 2034in 8 yr 6 mo
U-2970
9795604Oct 24, 2034in 8 yr 6 mo
U-2969
10463668*PEDApr 24, 2035in 9 yr
10695350*PEDApr 24, 2035in 9 yr
9795604*PEDApr 24, 2035in 9 yr
10010507Mar 03, 2036in 9 yr 10 mo
Product
10213386Mar 03, 2036in 9 yr 10 mo
Product
10828259Mar 03, 2036in 9 yr 10 mo
Product
12551448Mar 03, 2036in 9 yr 10 mo
Product
9655857Mar 03, 2036in 9 yr 10 mo
Product
10010507*PEDSep 03, 2036in 10 yr 4 mo
10213386*PEDSep 03, 2036in 10 yr 4 mo
10828259*PEDSep 03, 2036in 10 yr 4 mo
9655857*PEDSep 03, 2036in 10 yr 4 mo
Agent CTA Background

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