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Orange Book drug · Brand (NDA)

Imbruvica

Ibrutinib

RLDNDA 205552 2 strengths Pharmacyclics LLC
Approved
Nov 13, 2013
Strengths
2
Listed patents
67
Applications
3

What does the FDA Orange Book show for Imbruvica?

Imbruvica contains Ibrutinib and appears in 3 FDA Orange Book applications. NDA 205552 is the lead filing, with 2 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
3; lead NDA 205552

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Pharmacyclics LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
67

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
4

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001140MGCAPSULEORALPrescriptionNone posted
RLDRS
00270MGCAPSULEORALPrescriptionNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Pharmacyclics LLC

The Orange Book identifies this organization as the applicant responsible for NDA 205552.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

67 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 24, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 205552 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-205552

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · NDA 205552
RLDRS
Strength
140MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 11 mo ago

  2. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    11 mo ago

  3. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    5 mo ago

  4. Today

  5. Patent 7514444 expires

    Listed drug substance patent expiration.

    in 5 mo

  6. Patent 8476284 expires

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

    in 5 mo

  7. Patent 8476284 expires

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

    in 5 mo

  8. Patent 8497277 expires

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

    in 5 mo

  9. Patent 8497277 expires

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

    in 5 mo

  10. Patent 8497277 expires

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

    in 5 mo

  11. Patent 8497277 expires

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

    in 5 mo

  12. Patent 8497277 expires

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

    in 5 mo

  13. Patent 8497277 expires

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

    in 5 mo

  14. Patent 8697711 expires

    Listed drug substance patent expiration.

    in 5 mo

  15. Patent 8703780 expires

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

    in 5 mo

  16. Patent 8735403 expires

    Listed drug substance patent expiration.

    in 5 mo

  17. Patent 8754091 expires

    Listed drug product patent expiration.

    in 5 mo

  18. Patent 8952015 expires

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

    in 5 mo

  19. Patent 8952015 expires

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

    in 5 mo

  20. Patent 8952015 expires

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

    in 5 mo

  21. Patent 8957079 expires

    Listed drug substance patent expiration.

    in 5 mo

  22. Patent 9181257 expires

    Listed drug substance patent expiration.

    in 5 mo

  23. Patent 8563563 expires

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

    in 9 mo

  24. Patent 8563563 expires

    Listed method-of-use patent (U-2219) expiration.

    in 9 mo

  25. Patent 8563563 expires

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

    in 9 mo

  26. Patent 8563563 expires

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

    in 9 mo

  27. Patent 7514444*PED expires

    Listed listed patent expiration.

    in 11 mo

  28. Patent 8476284*PED expires

    Listed listed patent expiration.

    in 11 mo

  29. Patent 8497277*PED expires

    Listed listed patent expiration.

    in 11 mo

  30. Patent 8697711*PED expires

    Listed listed patent expiration.

    in 11 mo

  31. Patent 8703780*PED expires

    Listed listed patent expiration.

    in 11 mo

  32. Patent 8735403*PED expires

    Listed listed patent expiration.

    in 11 mo

  33. Patent 8754091*PED expires

    Listed listed patent expiration.

    in 11 mo

  34. Patent 8952015*PED expires

    Listed listed patent expiration.

    in 11 mo

  35. Patent 8957079*PED expires

    Listed listed patent expiration.

    in 11 mo

  36. Patent 9181257*PED expires

    Listed listed patent expiration.

    in 11 mo

  37. Patent 8563563*PED expires

    Listed listed patent expiration.

    in 1 yr 3 mo

  38. Patent 8008309 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  39. Patent 8008309*PED expires

    Listed listed patent expiration.

    in 1 yr 10 mo

  40. Exclusivity ends · ODE-405

    Orphan-drug exclusivity (7 years)

    in 3 yr 2 mo

  41. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

  42. Patent 10004746 expires

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

    in 4 yr 11 mo

  43. Patent 10004746 expires

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

    in 4 yr 11 mo

  44. Patent 10004746 expires

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

    in 4 yr 11 mo

  45. Patent 10004746 expires

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

    in 4 yr 11 mo

  46. Patent 10016435 expires

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

    in 4 yr 11 mo

  47. Patent 10478439 expires

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

    in 4 yr 11 mo

  48. Patent 10478439 expires

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

    in 4 yr 11 mo

  49. Patent 10478439 expires

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

    in 4 yr 11 mo

  50. Patent 10478439 expires

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

    in 4 yr 11 mo

  51. Patent 10478439 expires

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

    in 4 yr 11 mo

  52. Patent 10478439 expires

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

    in 4 yr 11 mo

  53. Patent 10478439 expires

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

    in 4 yr 11 mo

  54. Patent 10751342 expires

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

    in 4 yr 11 mo

  55. Patent 10751342 expires

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

    in 4 yr 11 mo

  56. Patent 10751342 expires

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

    in 4 yr 11 mo

  57. Patent 10751342 expires

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

    in 4 yr 11 mo

  58. Patent 11672803 expires

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

    in 4 yr 11 mo

  59. Patent 11672803 expires

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

    in 4 yr 11 mo

  60. Patent 11672803 expires

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

    in 4 yr 11 mo

  61. Patent 11672803 expires

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

    in 4 yr 11 mo

  62. Patent 8999999 expires

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

    in 4 yr 11 mo

  63. Patent 8999999 expires

    Listed method-of-use patent (U-1683) expiration.

    in 4 yr 11 mo

  64. Patent 9125889 expires

    Listed method-of-use patent (U-1745) expiration.

    in 4 yr 11 mo

  65. Patent 9801881 expires

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

    in 4 yr 11 mo

  66. Patent 9801883 expires

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

    in 4 yr 11 mo

  67. Patent 10004746*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  68. Patent 10016435*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  69. Patent 10478439*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  70. Patent 10751342*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  71. Patent 8999999*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  72. Patent 9125889*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  73. Patent 9801881*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  74. Patent 9801883*PED expires

    Listed listed patent expiration.

    in 5 yr 5 mo

  75. Patent 10106548 expires

    Listed drug substance patent expiration.

    in 6 yr 11 mo

  76. Patent 10125140 expires

    Listed drug substance patent expiration.

    in 6 yr 11 mo

  77. Patent 10294231 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  78. Patent 10294232 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  79. Patent 10752634 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  80. Patent 10961251 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  81. Patent 9713617 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  82. Patent 9725455 expires

    Listed drug substance patent expiration.

    in 6 yr 11 mo

  83. Patent 9540382 expires

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

    in 7 yr 2 mo

  84. Patent 9540382 expires

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

    in 7 yr 2 mo

  85. Patent 9540382 expires

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

    in 7 yr 2 mo

  86. Patent 9296753 expires

    Listed drug substance patent expiration.

    in 7 yr 4 mo

  87. Patent 10106548*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  88. Patent 10125140*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  89. Patent 10294231*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  90. Patent 10294232*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  91. Patent 10752634*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  92. Patent 10961251*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  93. Patent 9713617*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  94. Patent 9725455*PED expires

    Listed listed patent expiration.

    in 7 yr 6 mo

  95. Patent 9540382*PED expires

    Listed listed patent expiration.

    in 7 yr 8 mo

  96. Patent 9296753*PED expires

    Listed listed patent expiration.

    in 7 yr 11 mo

  97. Patent 10463668 expires

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

    in 8 yr 4 mo

  98. Patent 10695350 expires

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

    in 8 yr 4 mo

  99. Patent 9795604 expires

    Listed method-of-use patent (U-2150) expiration.

    in 8 yr 4 mo

  100. Patent 9795604 expires

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

    in 8 yr 4 mo

  101. Patent 9795604 expires

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

    in 8 yr 4 mo

  102. Patent 9795604 expires

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

    in 8 yr 4 mo

  103. Patent 10463668*PED expires

    Listed listed patent expiration.

    in 8 yr 10 mo

  104. Patent 10695350*PED expires

    Listed listed patent expiration.

    in 8 yr 10 mo

  105. Patent 9795604*PED expires

    Listed listed patent expiration.

    in 8 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202520272029203120332035TodayExclusivity NPP: 2025-08-24Exclusivity NPPExclusivity PED: 2026-02-24Exclusivity PEDPatent 7514444: 2026-12-28Patent 7514444Patent 8476284: 2026-12-28Patent 8476284Patent 8476284: 2026-12-28Patent 8476284Patent 8497277: 2026-12-28Patent 8497277Patent 8497277: 2026-12-28Patent 8497277Patent 8497277: 2026-12-28Patent 8497277Patent 8497277: 2026-12-28Patent 8497277Patent 8497277: 2026-12-28Patent 8497277Patent 8497277: 2026-12-28Patent 8497277Patent 8697711: 2026-12-28Patent 8697711Patent 8703780: 2026-12-28Patent 8703780Patent 8735403: 2026-12-28Patent 8735403Patent 8754091: 2026-12-28Patent 8754091Patent 8952015: 2026-12-28Patent 8952015Patent 8952015: 2026-12-28Patent 8952015Patent 8952015: 2026-12-28Patent 8952015Patent 8957079: 2026-12-28Patent 8957079Patent 9181257: 2026-12-28Patent 9181257Patent 8563563: 2027-04-26Patent 8563563Patent 8563563: 2027-04-26Patent 8563563Patent 8563563: 2027-04-26Patent 8563563Patent 8563563: 2027-04-26Patent 8563563Patent 7514444*PED: 2027-06-28Patent 7514444*PEDPatent 8476284*PED: 2027-06-28Patent 8476284*PEDPatent 8497277*PED: 2027-06-28Patent 8497277*PEDPatent 8697711*PED: 2027-06-28Patent 8697711*PEDPatent 8703780*PED: 2027-06-28Patent 8703780*PEDPatent 8735403*PED: 2027-06-28Patent 8735403*PEDPatent 8754091*PED: 2027-06-28Patent 8754091*PEDPatent 8952015*PED: 2027-06-28Patent 8952015*PEDPatent 8957079*PED: 2027-06-28Patent 8957079*PEDPatent 9181257*PED: 2027-06-28Patent 9181257*PEDPatent 8563563*PED: 2027-10-26Patent 8563563*PEDPatent 8008309: 2027-11-13Patent 8008309Patent 8008309*PED: 2028-05-13Patent 8008309*PEDExclusivity ODE-405: 2029-08-24Exclusivity ODE-405Exclusivity PED: 2030-02-24Exclusivity PEDPatent 10004746: 2031-06-03Patent 10004746Patent 10004746: 2031-06-03Patent 10004746Patent 10004746: 2031-06-03Patent 10004746Patent 10004746: 2031-06-03Patent 10004746Patent 10016435: 2031-06-03Patent 10016435Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10478439: 2031-06-03Patent 10478439Patent 10751342: 2031-06-03Patent 10751342Patent 10751342: 2031-06-03Patent 10751342Patent 10751342: 2031-06-03Patent 10751342Patent 10751342: 2031-06-03Patent 10751342Patent 11672803: 2031-06-03Patent 11672803Patent 11672803: 2031-06-03Patent 11672803Patent 11672803: 2031-06-03Patent 11672803Patent 11672803: 2031-06-03Patent 11672803Patent 8999999: 2031-06-03Patent 8999999Patent 8999999: 2031-06-03Patent 8999999Patent 9125889: 2031-06-03Patent 9125889Patent 9801881: 2031-06-03Patent 9801881Patent 9801883: 2031-06-03Patent 9801883Patent 10004746*PED: 2031-12-03Patent 10004746*PEDPatent 10016435*PED: 2031-12-03Patent 10016435*PEDPatent 10478439*PED: 2031-12-03Patent 10478439*PEDPatent 10751342*PED: 2031-12-03Patent 10751342*PEDPatent 8999999*PED: 2031-12-03Patent 8999999*PEDPatent 9125889*PED: 2031-12-03Patent 9125889*PEDPatent 9801881*PED: 2031-12-03Patent 9801881*PEDPatent 9801883*PED: 2031-12-03Patent 9801883*PEDPatent 10106548: 2033-06-03Patent 10106548Patent 10125140: 2033-06-03Patent 10125140Patent 10294231: 2033-06-03Patent 10294231Patent 10294232: 2033-06-03Patent 10294232Patent 10752634: 2033-06-03Patent 10752634Patent 10961251: 2033-06-03Patent 10961251Patent 9713617: 2033-06-03Patent 9713617Patent 9725455: 2033-06-03Patent 9725455Patent 9540382: 2033-08-18Patent 9540382Patent 9540382: 2033-08-18Patent 9540382Patent 9540382: 2033-08-18Patent 9540382Patent 9296753: 2033-10-30Patent 9296753Patent 10106548*PED: 2033-12-03Patent 10106548*PEDPatent 10125140*PED: 2033-12-03Patent 10125140*PEDPatent 10294231*PED: 2033-12-03Patent 10294231*PEDPatent 10294232*PED: 2033-12-03Patent 10294232*PEDPatent 10752634*PED: 2033-12-03Patent 10752634*PEDPatent 10961251*PED: 2033-12-03Patent 10961251*PEDPatent 9713617*PED: 2033-12-03Patent 9713617*PEDPatent 9725455*PED: 2033-12-03Patent 9725455*PEDPatent 9540382*PED: 2034-02-18Patent 9540382*PEDPatent 9296753*PED: 2034-04-30Patent 9296753*PEDPatent 10463668: 2034-10-24Patent 10463668Patent 10695350: 2034-10-24Patent 10695350Patent 9795604: 2034-10-24Patent 9795604Patent 9795604: 2034-10-24Patent 9795604Patent 9795604: 2034-10-24Patent 9795604Patent 9795604: 2034-10-24Patent 9795604Patent 10463668*PED: 2035-04-24Patent 10463668*PEDPatent 10695350*PED: 2035-04-24Patent 10695350*PEDPatent 9795604*PED: 2035-04-24Patent 9795604*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

IBRUTINIB

Strength

140MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205552

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NPPNew patient population exclusivity (3 years)

    11 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    5 mo ago

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

    in 3 yr 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7514444in 5 mo
SubstanceProduct
8476284in 5 mo
U-1650
8476284in 5 mo
U-1946
8497277in 5 mo
U-1491
8497277in 5 mo
U-1946
8497277in 5 mo
U-2242
8497277in 5 mo
U-2241
8497277in 5 mo
U-3422
8497277in 5 mo
U-1650
8697711in 5 mo
SubstanceProduct
8703780in 5 mo
U-1491
8735403in 5 mo
SubstanceProduct
8754091in 5 mo
Product
8952015in 5 mo
U-1650
8952015in 5 mo
U-1491
8952015in 5 mo
U-1946
8957079in 5 mo
SubstanceProduct
9181257in 5 mo
SubstanceProduct
8563563in 9 mo
U-1946
8563563in 9 mo
U-2219
8563563in 9 mo
U-1650
8563563in 9 mo
U-1491
7514444*PEDin 11 mo
8476284*PEDin 11 mo
8497277*PEDin 11 mo
8697711*PEDin 11 mo
8703780*PEDin 11 mo
8735403*PEDin 11 mo
8754091*PEDin 11 mo
8952015*PEDin 11 mo
8957079*PEDin 11 mo
9181257*PEDin 11 mo
8563563*PEDin 1 yr 3 mo
8008309in 1 yr 4 mo
SubstanceProduct
8008309*PEDin 1 yr 10 mo
10004746in 4 yr 11 mo
U-2242
10004746in 4 yr 11 mo
U-2241
10004746in 4 yr 11 mo
U-1946
10004746in 4 yr 11 mo
U-1684
10016435in 4 yr 11 mo
U-1650
10478439in 4 yr 11 mo
U-1946
10478439in 4 yr 11 mo
U-2665
10478439in 4 yr 11 mo
U-1650
10478439in 4 yr 11 mo
U-2241
10478439in 4 yr 11 mo
U-2242
10478439in 4 yr 11 mo
U-1684
10478439in 4 yr 11 mo
U-3422
10751342in 4 yr 11 mo
U-2944
10751342in 4 yr 11 mo
U-1946
10751342in 4 yr 11 mo
U-1491
10751342in 4 yr 11 mo
U-2943
11672803in 4 yr 11 mo
U-1684
11672803in 4 yr 11 mo
U-2242
11672803in 4 yr 11 mo
U-2241
11672803in 4 yr 11 mo
U-1946
8999999in 4 yr 11 mo
U-1684
8999999in 4 yr 11 mo
U-1683
9125889in 4 yr 11 mo
U-1745
9801881in 4 yr 11 mo
U-1491
9801883in 4 yr 11 mo
U-2159
10004746*PEDin 5 yr 5 mo
10016435*PEDin 5 yr 5 mo
10478439*PEDin 5 yr 5 mo
10751342*PEDin 5 yr 5 mo
8999999*PEDin 5 yr 5 mo
9125889*PEDin 5 yr 5 mo
9801881*PEDin 5 yr 5 mo
9801883*PEDin 5 yr 5 mo
10106548in 6 yr 11 mo
SubstanceProduct
10125140in 6 yr 11 mo
SubstanceProduct
10294231in 6 yr 11 mo
Product
10294232in 6 yr 11 mo
Product
10752634in 6 yr 11 mo
Product
10961251in 6 yr 11 mo
Product
9713617in 6 yr 11 mo
Product
9725455in 6 yr 11 mo
Substance
9540382in 7 yr 2 mo
U-1650
9540382in 7 yr 2 mo
U-1946
9540382in 7 yr 2 mo
U-1684
9296753in 7 yr 4 mo
SubstanceProduct
10106548*PEDin 7 yr 6 mo
10125140*PEDin 7 yr 6 mo
10294231*PEDin 7 yr 6 mo
10294232*PEDin 7 yr 6 mo
10752634*PEDin 7 yr 6 mo
10961251*PEDin 7 yr 6 mo
9713617*PEDin 7 yr 6 mo
9725455*PEDin 7 yr 6 mo
9540382*PEDin 7 yr 8 mo
9296753*PEDin 7 yr 11 mo
10463668in 8 yr 4 mo
U-2654
10695350in 8 yr 4 mo
U-2846
9795604in 8 yr 4 mo
U-2150
9795604in 8 yr 4 mo
U-3422
9795604in 8 yr 4 mo
U-2970
9795604in 8 yr 4 mo
U-2969
10463668*PEDin 8 yr 10 mo
10695350*PEDin 8 yr 10 mo
9795604*PEDin 8 yr 10 mo

Other FDA applications for Imbruvica

2 additional filings

The FDA has approved 3 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Imbruvica, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 210563Pharmacyclics LLCFeb 16, 20184—Prescription
NDA 217003Pharmacyclics LLCAug 24, 20221—Prescription

Active-ingredient family

Brand + generics

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

View full Ibrutinib family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Imbruvica: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 205552 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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