ibrutinib indications/contra

Stem definitionDrug idCAS RN
tyrosine kinase inhibitors 4810 936563-96-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • imbruvica
  • PCI-32765
  • CRA-032765
  • PCI-32765-00
  • ibrutinib
Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK's role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
  • Molecular weight: 440.51
  • Formula: C25H24N6O2
  • CLOGP: 4.07
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 99.16
  • ALOGS: -4.34
  • ROTB: 5

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 21, 2014 EMA
Nov. 13, 2013 FDA PHARMACYCLICS INC

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Atrial fibrillation 1381.67 38.82 419 5274 23522 3356644
Off label use 737.05 38.82 327 5366 53650 3326516
Diarrhoea 693.83 38.82 387 5306 103961 3276205
Pneumonia 655.21 38.82 327 5366 69816 3310350
Fatigue 648.63 38.82 374 5319 106866 3273300
Contusion 630.14 38.82 207 5486 14803 3365363
Disease progression 522.33 38.82 221 5472 32038 3348128
Haemoglobin decreased 508.62 38.82 213 5480 30081 3350085
White blood cell count increased 495.24 38.82 166 5527 12594 3367572
Death 493.16 38.82 359 5334 151965 3228201
Incorrect dose administered 481.15 38.82 166 5527 13748 3366418
Platelet count decreased 477.31 38.82 198 5495 27270 3352896
Haemorrhage 447.92 38.82 173 5520 19748 3360418
Product use issue 348.85 38.82 136 5557 15865 3364301
Thrombocytopenia 340.86 38.82 169 5524 35099 3345067
Pleural effusion 331.15 38.82 137 5556 18642 3361524
Subdural haematoma 327.00 38.82 95 5598 4460 3375706
Epistaxis 315.54 38.82 123 5570 14328 3365838
Lymphocytosis 288.67 38.82 60 5633 663 3379503
Neutropenia 287.35 38.82 148 5545 33238 3346928
Pyrexia 278.22 38.82 199 5494 80916 3299250
Asthenia 271.93 38.82 181 5512 65484 3314682
Anaemia 269.93 38.82 168 5525 54165 3326001
Arthralgia 269.59 38.82 175 5518 60686 3319480
Petechiae 253.73 38.82 71 5622 2903 3377263
Fall 250.17 38.82 165 5528 58718 3321448
Sepsis 237.31 38.82 129 5564 32244 3347922
Haematoma 229.67 38.82 82 5611 7457 3372709
Cerebral haemorrhage 226.02 38.82 87 5606 9767 3370399
Haematuria 225.18 38.82 87 5606 9865 3370301

Pharmacologic Action:

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SourceCodeDescription
ATC L01XE27 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Protein kinase inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
FDA EPC N0000175605 Kinase Inhibitor
FDA MoA N0000175076 Protein Kinase Inhibitors

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006 DOID:1040
Waldenström macroglobulinemia indication 190818004 DOID:9080
Chronic graft-versus-host disease indication 402356004
Mantle cell lymphoma indication 443487006
Pregnancy, function contraindication 289908002

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.7 Basic
pKa2 0.18 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9125889 June 3, 2031 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Jan. 29, 2018 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
70MG IMBRUVICA PHARMACYCLICS INC N205552 Dec. 20, 2017 RX CAPSULE ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
140MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
280MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
420MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
560MG IMBRUVICA PHARMACYCLICS INC N210563 Feb. 16, 2018 RX TABLET ORAL Nov. 13, 2018 NEW CHEMICAL ENTITY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL March 4, 2019 PROVIDES FOR THE FRONTLINE INDICATION FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL May 6, 2019 DOSING RECOMMENDATION ADDED TO THE LABELING FOR IMBRUVICA USE IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LEUKEMIA (SLL)
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL May 6, 2019 REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL)
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL May 6, 2019 REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL) WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Jan. 18, 2020 TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Aug. 2, 2020 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Nov. 13, 2020 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Feb. 12, 2021 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL July 28, 2021 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Jan. 29, 2022 TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL March 4, 2023 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL May 6, 2023 FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Jan. 18, 2024 TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
140MG IMBRUVICA PHARMACYCLICS INC N205552 Nov. 13, 2013 RX CAPSULE ORAL Aug. 2, 2024 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tyrosine-protein kinase BTK Kinase INHIBITOR Ki 9.14 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Tyrosine-protein kinase Lyn Kinase Ki 7.85 SCIENTIFIC LITERATURE
Epidermal growth factor receptor Kinase IC50 8.25 CHEMBL
Cytoplasmic tyrosine-protein kinase BMX Kinase IC50 9.10 CHEMBL
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 7.43 CHEMBL
Fibroblast growth factor receptor 2 Kinase IC50 6.55 CHEMBL
Tyrosine-protein kinase Blk Kinase INHIBITOR IC50 10 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Fgr Kinase INHIBITOR IC50 8.48 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Fyn Kinase INHIBITOR IC50 7.54 SCIENTIFIC LITERATURE
Tyrosine-protein kinase HCK Kinase INHIBITOR IC50 7.54 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Lck Kinase INHIBITOR IC50 8.20 SCIENTIFIC LITERATURE
Proto-oncogene tyrosine-protein kinase Src Kinase INHIBITOR IC50 7.72 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Yes Kinase INHIBITOR IC50 8.39 SCIENTIFIC LITERATURE
Tyrosine-protein kinase ITK/TSK Kinase INHIBITOR IC50 8.31 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Tec Kinase INHIBITOR IC50 8.15 SCIENTIFIC LITERATURE
Tyrosine-protein kinase TXK Kinase INHIBITOR IC50 8.70 SCIENTIFIC LITERATURE
Receptor tyrosine-protein kinase erbB-2 Kinase INHIBITOR IC50 8.19 SCIENTIFIC LITERATURE
Receptor tyrosine-protein kinase erbB-4 Kinase INHIBITOR IC50 8.47 SCIENTIFIC LITERATURE
Tyrosine-protein kinase JAK3 Kinase INHIBITOR IC50 7.49 SCIENTIFIC LITERATURE

External reference:

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IDSource
CHEBI:76612 CHEBI
6912 IUPHAR_LIGAND_ID
D10223 KEGG_DRUG
C3692993 UMLSCUI
1X70OSD4VX UNII
9566 INN_ID
1442981 RXNORM
29840 MMSL
d08170 MMSL
015287 NDDF
4032872 VANDF
N0000189502 NDFRT
710228002 SNOMEDCT_US
715598009 SNOMEDCT_US
C551803 MESH_SUPPLEMENTAL_RECORD_UI
DB09053 DRUGBANK_ID
CHEMBL1873475 ChEMBL_ID
24821094 PUBCHEM_CID
1E8 PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
IMBRUVICA HUMAN PRESCRIPTION DRUG LABEL 1 57962-560 TABLET, FILM COATED 560 mg ORAL NDA 19 sections