ibrutinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

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: 4.04
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 99.16
  • ALOGS: -4.34
  • ROTB: 5
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.42 g O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 9.75 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 16.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 21, 2014 EMA
Nov. 13, 2013 FDA PHARMACYCLICS INC
March 28, 2016 PMDA Janssen Pharmaceutical

FDA Adverse Event Reporting System (Female)

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
Death 818.80 16.63 805 20751 373576 63093890
Atrial fibrillation 400.62 16.63 325 21231 116311 63351155
Incorrect dose administered 275.77 16.63 199 21357 59769 63407697
Off label use 254.95 16.63 644 20912 673818 62793648
Disease progression 231.60 16.63 245 21311 122513 63344953
Contusion 144.71 16.63 214 21342 149830 63317636
Petechiae 142.85 16.63 77 21479 13820 63453646
Lymphadenopathy 133.45 16.63 108 21448 38350 63429116
Hospice care 132.10 16.63 61 21495 7871 63459595
White blood cell count increased 123.14 16.63 114 21442 48447 63419019
Platelet count decreased 108.13 16.63 163 21393 115959 63351507
Tumour lysis syndrome 107.14 16.63 55 21501 8935 63458531
Lymphocytosis 103.57 16.63 38 21518 2729 63464737
Pleural effusion 92.73 16.63 135 21421 93075 63374391
Drug ineffective 89.47 16.63 136 21420 1044629 62422837
Pericardial effusion 84.90 16.63 75 21481 29983 63437483
Thrombocytopenia 82.86 16.63 168 21388 150989 63316477
Drug hypersensitivity 82.52 16.63 6 21550 310681 63156785
Haemorrhage 76.71 16.63 99 21457 60923 63406543
Diffuse large B-cell lymphoma recurrent 76.38 16.63 29 21527 2291 63465175
Subdural haematoma 76.12 16.63 52 21504 14276 63453190
Haematoma 75.48 16.63 75 21481 34745 63432721
Vasogenic cerebral oedema 72.50 16.63 22 21534 874 63466592
Haemorrhage intracranial 72.00 16.63 49 21507 13370 63454096
Epistaxis 70.38 16.63 104 21452 72621 63394845
Aspergillus infection 67.24 16.63 39 21517 8054 63459412
Progressive multifocal leukoencephalopathy 66.37 16.63 46 21510 12925 63454541
Ecchymosis 65.51 16.63 43 21513 11051 63456415
Onychoclasis 65.40 16.63 35 21521 6187 63461279
Lymphocyte count increased 65.19 16.63 29 21527 3429 63464037
Rheumatoid arthritis 64.34 16.63 6 21550 253813 63213653
Hospitalisation 63.46 16.63 108 21448 84973 63382493
Chronic lymphocytic leukaemia recurrent 63.07 16.63 15 21541 229 63467237
COVID-19 62.29 16.63 126 21430 112977 63354489
Pain 61.67 16.63 98 21458 740530 62726936
Infusion related reaction 59.16 16.63 7 21549 245514 63221952
Contraindicated product administered 58.35 16.63 4 21552 217644 63249822
Arthropathy 58.32 16.63 6 21550 234786 63232680
Cerebral haemorrhage 57.21 16.63 61 21495 30668 63436798
Neutropenia 57.15 16.63 159 21397 174846 63292620
Pneumonia 54.19 16.63 301 21255 456466 63011000
Lymphoma 52.66 16.63 39 21517 12148 63455318
Diffuse large B-cell lymphoma 52.22 16.63 31 21525 6681 63460785
Neurological symptom 48.39 16.63 28 21528 5755 63461711
Febrile neutropenia 48.30 16.63 117 21439 118332 63349134
Therapy partial responder 48.07 16.63 35 21521 10623 63456843
Hypogammaglobulinaemia 47.86 16.63 30 21526 7125 63460341
Condition aggravated 47.66 16.63 40 21516 402177 63065289
Haemoglobin decreased 46.32 16.63 131 21425 145354 63322112
Increased tendency to bruise 46.11 16.63 34 21522 10518 63456948
Cytopenia 45.42 16.63 35 21521 11566 63455900
Neutrophil count decreased 45.25 16.63 74 21482 56332 63411134
Capillary permeability increased 44.34 16.63 8 21548 26 63467440
Sepsis 44.07 16.63 133 21423 152990 63314476
Cerebral aspergillosis 41.28 16.63 12 21544 410 63467056
Therapeutic product effect decreased 40.84 16.63 8 21548 193179 63274287
Autoimmune haemolytic anaemia 40.43 16.63 23 21533 4578 63462888
Chronic lymphocytic leukaemia 40.11 16.63 19 21537 2595 63464871
Hepatic enzyme increased 39.50 16.63 10 21546 202318 63265148
Urinary tract infection 39.38 16.63 186 21370 264498 63202968
Mantle cell lymphoma recurrent 39.05 16.63 10 21546 210 63467256
Leukocytosis 38.89 16.63 46 21510 25889 63441577
Blood blister 38.78 16.63 17 21539 1941 63465525
Swelling 38.36 16.63 23 21533 275355 63192111
Completed suicide 38.10 16.63 3 21553 145670 63321796
Haematotympanum 37.77 16.63 6 21550 6 63467460
Campylobacter infection 37.41 16.63 14 21542 1062 63466404
Abdominal discomfort 36.67 16.63 33 21523 320852 63146614
Muscle spasms 36.22 16.63 126 21430 156024 63311442
Wound 36.15 16.63 6 21550 163257 63304209
Splenomegaly 35.88 16.63 30 21526 11127 63456339
Eye haemorrhage 34.06 16.63 26 21530 8470 63458996
Product use in unapproved indication 33.61 16.63 135 21421 178945 63288521
Discomfort 33.20 16.63 8 21548 167366 63300100
Musculoskeletal stiffness 32.60 16.63 11 21545 184607 63282859
Hypersensitivity 32.37 16.63 31 21525 292654 63174812
Hyperuricaemia 32.15 16.63 21 21535 5349 63462117
Non-small cell lung cancer 31.67 16.63 18 21538 3577 63463889
Bronchopulmonary aspergillosis 31.53 16.63 25 21531 8610 63458856
Joint swelling 31.49 16.63 39 21517 327627 63139839
Chronic lymphocytic leukaemia refractory 29.11 16.63 6 21550 45 63467421
Diarrhoea 28.58 16.63 369 21187 714997 62752469
Hyperphosphataemia 27.50 16.63 14 21542 2234 63465232
Haematuria 27.19 16.63 41 21515 29116 63438350
Fall 26.35 16.63 225 21331 392109 63075357
COVID-19 pneumonia 26.08 16.63 28 21528 14181 63453285
Anaemia 25.66 16.63 179 21377 293251 63174215
Purpura 25.55 16.63 25 21531 11360 63456106
Septic shock 25.22 16.63 64 21492 66565 63400901
Haemothorax 24.97 16.63 13 21543 2172 63465294
Cardiac failure 24.29 16.63 76 21480 89066 63378400
Neutropenic infection 24.29 16.63 11 21545 1356 63466110
Splenic haematoma 24.20 16.63 6 21550 110 63467356
Ear haemorrhage 23.74 16.63 11 21545 1429 63466037
Chronic lymphocytic leukaemia transformation 22.37 16.63 5 21551 57 63467409
Asthma 21.83 16.63 8 21548 127553 63339913
Urosepsis 21.63 16.63 29 21527 18495 63448971
Helicobacter infection 21.47 16.63 3 21553 92782 63374684
Meningitis cryptococcal 21.10 16.63 10 21546 1367 63466099
Atrial flutter 21.08 16.63 21 21535 9751 63457715
Haemorrhagic diathesis 21.05 16.63 15 21541 4400 63463066
Drug intolerance 21.00 16.63 46 21510 308615 63158851
Oligospermia 20.97 16.63 3 21553 0 63467466
Alopecia 20.82 16.63 53 21503 337483 63129983
Full blood count abnormal 20.70 16.63 38 21518 31679 63435787
Breast haematoma 20.50 16.63 6 21550 210 63467256
Mobility decreased 20.06 16.63 8 21548 121151 63346315
Sudden death 19.90 16.63 21 21535 10428 63457038
Hypercalcaemia 19.85 16.63 35 21521 28287 63439179
Pancytopenia 19.73 16.63 75 21481 96858 63370608
Pyrexia 19.70 16.63 245 21311 470233 62997233
Psoriasis 19.68 16.63 3 21553 86954 63380512
Pericardial haemorrhage 19.56 16.63 10 21546 1609 63465857
Campylobacter gastroenteritis 19.50 16.63 7 21549 472 63466994
Blood lactate dehydrogenase increased 19.45 16.63 31 21525 23085 63444381
Blister 19.27 16.63 10 21546 129804 63337662
Nonspecific reaction 18.92 16.63 11 21545 2281 63465185
Discouragement 18.83 16.63 9 21547 1253 63466213
Skin haemorrhage 18.71 16.63 20 21536 10074 63457392
Migraine 18.51 16.63 6 21550 103340 63364126
White blood cell count abnormal 18.47 16.63 16 21540 6226 63461240
Splenic rupture 18.33 16.63 9 21547 1329 63466137
Gingival bleeding 18.33 16.63 22 21534 12565 63454901
Chronic graft versus host disease 18.25 16.63 12 21544 3090 63464376
Pneumonia fungal 18.23 16.63 15 21541 5440 63462026
Product use complaint 18.14 16.63 11 21545 2463 63465003
Therapeutic product effect incomplete 18.02 16.63 10 21546 125046 63342420
Skin lesion 17.82 16.63 35 21521 30686 63436780
Leukostasis syndrome 17.71 16.63 4 21552 48 63467418
Dyspnoea 17.63 16.63 142 21414 661171 62806295
Spinal fracture 17.47 16.63 26 21530 18245 63449221
Nausea 17.06 16.63 197 21359 854274 62613192
Bacteraemia 17.04 16.63 25 21531 17323 63450143
Overdose 16.88 16.63 9 21547 115069 63352397
Hyperviscosity syndrome 16.84 16.63 5 21551 184 63467282

FDA Adverse Event Reporting System (Male)

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
Death 839.81 13.73 1583 39149 396466 34519733
Atrial fibrillation 759.09 13.73 818 39914 121575 34794624
Incorrect dose administered 363.80 13.73 332 40400 40183 34876016
Off label use 278.25 13.73 1091 39641 418433 34497766
Disease progression 276.38 13.73 470 40262 107607 34808592
Lymphocytosis 229.38 13.73 93 40639 2484 34913715
Contusion 226.04 13.73 244 40488 36120 34880079
Lymphocyte count increased 208.66 13.73 94 40638 3271 34912928
Haemorrhage 191.13 13.73 266 40466 51104 34865095
Lymphadenopathy 180.39 13.73 193 40539 28270 34887929
Pleural effusion 150.98 13.73 309 40423 81237 34834962
White blood cell count increased 149.92 13.73 211 40521 40940 34875259
Mantle cell lymphoma recurrent 136.44 13.73 46 40686 717 34915482
Platelet count decreased 126.21 13.73 365 40367 119352 34796847
Toxicity to various agents 125.14 13.73 39 40693 200323 34715876
Cerebral aspergillosis 121.70 13.73 50 40682 1382 34914817
Pneumonia 120.42 13.73 777 39955 361850 34554349
Bronchopulmonary aspergillosis 119.60 13.73 114 40618 14545 34901654
Subdural haematoma 116.39 13.73 131 40601 20290 34895909
Haematoma 104.87 13.73 139 40593 25466 34890733
Petechiae 100.05 13.73 85 40647 9333 34906866
Tumour lysis syndrome 99.89 13.73 111 40621 16948 34899251
Completed suicide 97.12 13.73 4 40728 98164 34818035
Hypogammaglobulinaemia 92.94 13.73 75 40657 7665 34908534
Hospice care 91.38 13.73 71 40661 6869 34909330
Pericardial effusion 86.15 13.73 124 40608 24538 34891661
Haemothorax 82.36 13.73 53 40679 3799 34912400
Product use issue 81.80 13.73 208 40524 63008 34853191
Basal cell carcinoma 80.93 13.73 107 40625 19551 34896648
COVID-19 78.31 13.73 233 40499 77317 34838882
Atrial flutter 75.56 13.73 92 40640 15482 34900717
Increased tendency to bruise 75.01 13.73 51 40681 4010 34912189
Splenomegaly 72.85 13.73 89 40643 15028 34901171
Chronic lymphocytic leukaemia 68.47 13.73 49 40683 4183 34912016
Autoimmune haemolytic anaemia 68.06 13.73 50 40682 4446 34911753
Scleroderma 67.16 13.73 34 40698 1538 34914661
Epistaxis 63.58 13.73 180 40552 58071 34858128
Microsporidia infection 57.79 13.73 24 40708 682 34915517
Aspergillus infection 57.20 13.73 71 40661 12183 34904016
Overdose 56.27 13.73 18 40714 91041 34825158
Drug ineffective 55.28 13.73 310 40422 456441 34459758
Chronic lymphocytic leukaemia recurrent 55.17 13.73 20 40712 390 34915809
Post procedural haemorrhage 53.87 13.73 57 40675 8232 34907967
Surgery 53.61 13.73 74 40658 14083 34902116
Condition aggravated 52.13 13.73 90 40642 192106 34724093
Cerebral haemorrhage 51.60 13.73 121 40611 34816 34881383
Hospitalisation 50.04 13.73 163 40569 56739 34859460
Haemoglobin decreased 46.87 13.73 270 40462 120502 34795697
Neutrophil count decreased 46.39 13.73 148 40584 50956 34865243
Haematuria 46.37 13.73 146 40586 49920 34866279
COVID-19 pneumonia 44.81 13.73 75 40657 16892 34899307
Somnolence 43.78 13.73 39 40693 111077 34805122
Cardiac failure 43.57 13.73 216 40516 91032 34825167
Ecchymosis 42.83 13.73 46 40686 6757 34909442
Mantle cell lymphoma 42.62 13.73 24 40708 1348 34914851
White blood cell count abnormal 42.21 13.73 33 40699 3220 34912979
Agitation 41.94 13.73 8 40724 57391 34858808
Vomiting 40.64 13.73 150 40582 247471 34668728
Prostatic operation 40.14 13.73 16 40716 408 34915791
Nausea 39.78 13.73 233 40499 339675 34576524
Lymphocyte count decreased 39.76 13.73 84 40648 22538 34893661
Blood immunoglobulin M increased 39.56 13.73 14 40718 254 34915945
Mantle cell lymphoma refractory 39.47 13.73 11 40721 86 34916113
Subdural haemorrhage 38.47 13.73 31 40701 3160 34913039
Plasma cell myeloma 37.63 13.73 3 40729 42034 34874165
Intentional overdose 36.74 13.73 4 40728 43670 34872529
Pericardial haemorrhage 36.64 13.73 30 40702 3128 34913071
Chronic graft versus host disease 35.64 13.73 34 40698 4339 34911860
Haemorrhage subcutaneous 35.52 13.73 26 40706 2298 34913901
Onychoclasis 35.42 13.73 24 40708 1876 34914323
Splenic rupture 34.93 13.73 22 40710 1519 34914680
Brain abscess 34.82 13.73 29 40703 3096 34913103
Pericarditis 34.17 13.73 54 40678 11591 34904608
Intentional product misuse 34.09 13.73 6 40726 45605 34870594
Polymyositis 33.58 13.73 21 40711 1432 34914767
Blood blister 33.44 13.73 22 40710 1637 34914562
Anxiety 33.39 13.73 40 40692 99388 34816811
Squamous cell carcinoma 33.38 13.73 53 40679 11422 34904777
Drug hypersensitivity 33.25 13.73 27 40705 80502 34835697
Haemorrhagic diathesis 33.19 13.73 27 40705 2789 34913410
Platelet count abnormal 32.32 13.73 27 40705 2895 34913304
Metabolic acidosis 32.09 13.73 6 40726 43674 34872525
Pseudomonas infection 31.72 13.73 54 40678 12328 34903871
Neutropenia 31.67 13.73 300 40432 156478 34759721
Chronic lymphocytic leukaemia transformation 31.53 13.73 11 40721 191 34916008
Blood urine present 31.46 13.73 50 40682 10784 34905415
Haemorrhage intracranial 31.32 13.73 62 40670 15884 34900315
Febrile neutropenia 30.75 13.73 268 40464 136581 34779618
Suicide attempt 29.55 13.73 5 40727 39111 34877088
Angina bullosa haemorrhagica 29.36 13.73 8 40724 57 34916142
Rhabdomyolysis 29.22 13.73 22 40710 68141 34848058
Blood pressure decreased 28.74 13.73 12 40720 51503 34864696
Bone marrow transplant 28.69 13.73 17 40715 1051 34915148
Hypoglycaemia 28.49 13.73 14 40718 54626 34861573
Campylobacter infection 28.18 13.73 16 40716 913 34915286
Blood pressure increased 27.95 13.73 37 40695 88065 34828134
Product use in unapproved indication 27.91 13.73 233 40499 117266 34798933
Chronic graft versus host disease in skin 27.47 13.73 16 40716 958 34915241
Electrocardiogram QT prolonged 27.30 13.73 7 40725 40945 34875254
Depressed level of consciousness 27.29 13.73 8 40724 42833 34873366
Suicidal ideation 26.74 13.73 7 40725 40381 34875818
Infective exacerbation of chronic obstructive airways disease 26.70 13.73 20 40712 1831 34914368
Skin haemorrhage 26.62 13.73 30 40702 4648 34911551
Splenic haemorrhage 25.94 13.73 12 40720 444 34915755
Renal impairment 25.81 13.73 44 40688 94469 34821730
Iodine uptake abnormal 25.32 13.73 5 40727 5 34916194
Mass 25.07 13.73 38 40694 7867 34908332
Abdominal pain 24.95 13.73 102 40630 163516 34752683
Arrhythmia 24.93 13.73 95 40637 35713 34880486
Ear haemorrhage 24.80 13.73 15 40717 963 34915236
Lymphoma transformation 24.66 13.73 10 40722 267 34915932
Hepatitis E 24.59 13.73 20 40712 2066 34914133
Eye operation 24.37 13.73 11 40721 384 34915815
Hallucination 24.24 13.73 15 40717 51483 34864716
Stomatitis 24.21 13.73 106 40626 42408 34873791
Wheezing 24.15 13.73 9 40723 41393 34874806
Bacterial pericarditis 24.05 13.73 7 40725 65 34916134
Abdominal lymphadenopathy 24.01 13.73 14 40718 840 34915359
Bladder operation 23.65 13.73 8 40724 126 34916073
Haemolytic anaemia 23.36 13.73 43 40689 10436 34905763
Pruritus 23.25 13.73 86 40646 141895 34774304
Thrombocytopenia 23.14 13.73 281 40451 155966 34760233
Leukostasis syndrome 23.05 13.73 6 40726 35 34916164
Pulmonary mass 23.00 13.73 48 40684 12764 34903435
Musculoskeletal stiffness 22.81 13.73 13 40719 46667 34869532
Pyrexia 22.59 13.73 527 40205 332486 34583713
Mucormycosis 22.40 13.73 31 40701 5911 34910288
Herpes zoster 22.11 13.73 89 40643 34310 34881889
International normalised ratio increased 21.97 13.73 14 40718 47313 34868886
Pulmonary embolism 21.67 13.73 45 40687 89701 34826498
Immunodeficiency common variable 21.30 13.73 8 40724 173 34916026
Haemorrhagic disorder 21.26 13.73 12 40720 677 34915522
Leukocytosis 21.19 13.73 69 40663 23996 34892203
Tremor 21.16 13.73 40 40692 82547 34833652
Respiratory failure 21.03 13.73 206 40526 108366 34807833
Therapy partial responder 20.86 13.73 39 40693 9577 34906622
Flushing 20.75 13.73 6 40726 32414 34883785
Cardiac tamponade 20.65 13.73 28 40704 5238 34910961
Stress 20.59 13.73 5 40727 30342 34885857
Fungal abscess central nervous system 20.53 13.73 7 40725 113 34916086
Cardiomyopathy 20.37 13.73 54 40678 16754 34899445
Hypotension 20.36 13.73 163 40569 221486 34694713
Skin lesion 20.28 13.73 64 40668 21897 34894302
B-cell small lymphocytic lymphoma 20.26 13.73 8 40724 199 34916000
Eye haemorrhage 20.18 13.73 25 40707 4280 34911919
Psoriasis 20.15 13.73 10 40722 38802 34877397
Hypersensitivity 20.01 13.73 25 40707 61010 34855189
Immunodeficiency 19.71 13.73 28 40704 5470 34910729
Pyoderma gangrenosum 19.62 13.73 15 40717 1416 34914783
Meningitis enteroviral 19.53 13.73 5 40727 27 34916172
Loss of consciousness 19.50 13.73 42 40690 82625 34833574
Asthma 19.29 13.73 13 40719 42643 34873556
Acute kidney injury 19.03 13.73 246 40486 304742 34611457
Purpura 18.94 13.73 39 40693 10272 34905927
Blood urea increased 18.75 13.73 6 40726 30358 34885841
Sudden death 18.59 13.73 49 40683 15152 34901047
Pain 18.57 13.73 151 40581 204524 34711675
Cardiac disorder 18.41 13.73 99 40633 43027 34873172
Pneumonia cryptococcal 18.25 13.73 12 40720 892 34915307
Conjunctival haemorrhage 18.08 13.73 20 40712 3035 34913164
Loss of personal independence in daily activities 18.07 13.73 8 40724 33171 34883028
Urticaria 18.00 13.73 28 40704 62349 34853850
Sepsis 17.92 13.73 283 40449 166278 34749921
C-reactive protein increased 17.90 13.73 22 40710 54076 34862123
Speech disorder 17.89 13.73 4 40728 25682 34890517
Malaise 17.83 13.73 135 40597 185690 34730509
Confusional state 17.77 13.73 97 40635 144063 34772136
Gamma-glutamyltransferase increased 17.65 13.73 6 40726 29225 34886974
Cerebral fungal infection 17.60 13.73 8 40724 284 34915915
B-cell small lymphocytic lymphoma recurrent 17.49 13.73 4 40728 12 34916187
Aggression 17.45 13.73 12 40720 38952 34877247
Muscle spasms 17.41 13.73 148 40584 74853 34841346
Hyperhidrosis 17.40 13.73 39 40693 75653 34840546
Paraesthesia 17.40 13.73 30 40702 64142 34852057
Hepatitis B reactivation 17.29 13.73 22 40710 3869 34912330
Deep vein thrombosis 17.24 13.73 31 40701 65217 34850982
Chronic graft versus host disease in eye 17.10 13.73 6 40726 106 34916093
Myositis 16.94 13.73 41 40691 12029 34904170
Lymphoedema 16.79 13.73 22 40710 3981 34912218
Gastric haemorrhage 16.76 13.73 37 40695 10224 34905975
Transplant 16.76 13.73 11 40721 815 34915384
Heart rate decreased 16.75 13.73 8 40724 31737 34884462
Eosinophilia 16.51 13.73 5 40727 26217 34889982
Therapeutic product effect decreased 16.51 13.73 10 40722 34733 34881466
Human rhinovirus test positive 16.44 13.73 7 40725 212 34915987
Bradycardia 16.42 13.73 40 40692 75378 34840821
Procedural haemorrhage 16.15 13.73 17 40715 2440 34913759
Weight increased 16.12 13.73 55 40677 92978 34823221
Neck mass 15.99 13.73 14 40718 1599 34914600
Anaphylactic reaction 15.77 13.73 9 40723 32292 34883907
Arteriosclerotic retinopathy 15.72 13.73 4 40728 21 34916178
Cystoid macular oedema 15.69 13.73 10 40722 705 34915494
Pneumonia fungal 15.65 13.73 29 40703 7071 34909128
Blood glucose increased 15.65 13.73 34 40698 66684 34849515
Soft tissue infection 15.62 13.73 16 40716 2224 34913975
Skin cancer 15.56 13.73 36 40696 10261 34905938
Product use complaint 15.36 13.73 13 40719 1419 34914780
Skin mass 15.34 13.73 21 40711 3964 34912235
Abnormal behaviour 15.30 13.73 5 40727 24964 34891235
Papilloma excision 15.19 13.73 3 40729 3 34916196
Mastoid effusion 15.19 13.73 3 40729 3 34916196
Lymph node haemorrhage 15.19 13.73 3 40729 3 34916196
White blood cell count decreased 15.15 13.73 174 40558 95271 34820928
Scrotal haematocoele 15.13 13.73 4 40728 25 34916174
Altered state of consciousness 15.09 13.73 4 40728 22889 34893310
Hyperphosphataemia 15.03 13.73 22 40710 4415 34911784
Irritability 15.03 13.73 5 40727 24685 34891514
Dental operation 14.93 13.73 8 40724 407 34915792
Angioedema 14.84 13.73 13 40719 37361 34878838
Supraventricular tachycardia 14.79 13.73 37 40695 11080 34905119
Ureteric compression 14.79 13.73 7 40725 273 34915926
Aspartate aminotransferase increased 14.72 13.73 36 40696 67747 34848452
Cataract 14.68 13.73 65 40667 26121 34890078
Night sweats 14.60 13.73 49 40683 17303 34898896
Cryptococcosis 14.60 13.73 16 40716 2403 34913796
Granuloma skin 14.52 13.73 12 40720 1267 34914932
Thyroxine increased 14.43 13.73 5 40727 85 34916114
Lung operation 14.37 13.73 5 40727 86 34916113
Peripheral swelling 14.21 13.73 144 40588 76397 34839802
Restlessness 14.10 13.73 6 40726 25476 34890723
Hypomagnesaemia 14.06 13.73 4 40728 21847 34894352
Biopsy 14.05 13.73 7 40725 306 34915893
Application site laceration 13.98 13.73 3 40729 6 34916193
Supportive care 13.98 13.73 3 40729 6 34916193
Toxic epidermal necrolysis 13.86 13.73 4 40728 21642 34894557
Alanine aminotransferase increased 13.85 13.73 48 40684 80767 34835432
Seizure 13.79 13.73 69 40663 104788 34811411

FDA Adverse Event Reporting System (Geriatric)

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 1111.54 13.60 963 50841 196923 79495661
Death 640.48 13.60 1239 50565 565275 79127309
Incorrect dose administered 598.70 13.60 453 51351 76177 79616407
Off label use 355.56 13.60 1340 50464 905875 78786709
Disease progression 317.20 13.60 487 51317 183875 79508709
Lymphocytosis 280.44 13.60 108 51696 4585 79687999
Platelet count decreased 262.84 13.60 461 51343 194203 79498381
Lymphadenopathy 256.02 13.60 238 51566 53009 79639575
White blood cell count increased 247.78 13.60 273 51531 74360 79618224
Pleural effusion 243.10 13.60 379 51425 144883 79547701
Lymphocyte count increased 232.82 13.60 101 51703 5831 79686753
Petechiae 211.90 13.60 144 51660 20421 79672163
Pneumonia 211.03 13.60 917 50887 659329 79033255
Subdural haematoma 196.20 13.60 163 51641 31271 79661313
Tumour lysis syndrome 192.21 13.60 144 51660 23795 79668789
Contusion 191.25 13.60 345 51459 148431 79544153
Cerebral aspergillosis 185.52 13.60 62 51742 1734 79690850
Bronchopulmonary aspergillosis 185.47 13.60 137 51667 22157 79670427
Pericardial effusion 174.35 13.60 181 51623 46056 79646528
Haematoma 168.15 13.60 188 51616 52007 79640577
Completed suicide 141.14 13.60 4 51800 245763 79446821
Haemorrhage 138.94 13.60 228 51576 90890 79601694
Hypogammaglobulinaemia 124.71 13.60 87 51717 12864 79679720
Drug ineffective 122.84 13.60 332 51472 1080581 78612003
Drug hypersensitivity 122.40 13.60 23 51781 298893 79393691
Epistaxis 121.40 13.60 241 51563 111274 79581310
Aspergillus infection 120.89 13.60 100 51704 19061 79673523
Toxicity to various agents 115.79 13.60 65 51739 421475 79271109
Rheumatoid arthritis 114.10 13.60 5 51799 208465 79484119
Atrial flutter 112.36 13.60 101 51703 21524 79671060
Mantle cell lymphoma recurrent 109.19 13.60 32 51772 573 79692011
Condition aggravated 106.82 13.60 101 51703 501023 79191561
Thrombocytopenia 105.47 13.60 395 51409 264864 79427720
Neutrophil count decreased 102.18 13.60 203 51601 93756 79598828
Haemoglobin decreased 101.30 13.60 346 51458 221773 79470811
Increased tendency to bruise 100.07 13.60 70 51734 10394 79682190
Chronic lymphocytic leukaemia 99.61 13.60 53 51751 4813 79687771
Haematuria 97.91 13.60 167 51637 68669 79623915
COVID-19 97.33 13.60 273 51531 157401 79535183
Cerebral haemorrhage 94.28 13.60 149 51655 57524 79635060
Haemothorax 93.73 13.60 53 51751 5425 79687159
Ecchymosis 93.10 13.60 78 51726 15128 79677456
Cardiac failure 91.58 13.60 264 51540 154578 79538006
Neutropenia 90.17 13.60 398 51406 287312 79405272
Pain 90.01 13.60 203 51601 703599 78988985
Haemorrhage intracranial 88.91 13.60 97 51707 26096 79666488
Splenomegaly 88.75 13.60 87 51717 20667 79671917
Febrile neutropenia 86.86 13.60 338 51466 230661 79461923
Chronic lymphocytic leukaemia recurrent 85.78 13.60 27 51777 621 79691963
Autoimmune haemolytic anaemia 82.34 13.60 57 51747 8323 79684261
Nausea 76.12 13.60 342 51462 956854 78735730
Basal cell carcinoma 76.05 13.60 107 51697 37268 79655316
Arthropathy 76.03 13.60 12 51792 177099 79515485
Sepsis 74.98 13.60 360 51444 269068 79423516
Contraindicated product administered 74.04 13.60 8 51796 157530 79535054
COVID-19 pneumonia 73.17 13.60 92 51712 28757 79663827
Therapeutic product effect decreased 72.89 13.60 10 51794 163853 79528731
Overdose 71.58 13.60 16 51788 184190 79508394
Injection site pain 71.40 13.60 3 51801 129835 79562749
Campylobacter infection 67.53 13.60 30 51774 1833 79690751
Diffuse large B-cell lymphoma recurrent 64.77 13.60 38 51766 4169 79688415
Onychoclasis 64.55 13.60 42 51762 5536 79687048
Microsporidia infection 64.09 13.60 24 51780 942 79691642
Drug intolerance 62.58 13.60 48 51756 264071 79428513
Blood blister 61.74 13.60 33 51771 3024 79689560
Hypersensitivity 61.70 13.60 48 51756 262191 79430393
Leukocytosis 61.21 13.60 105 51699 43350 79649234
Musculoskeletal stiffness 60.79 13.60 19 51785 174989 79517595
Pyrexia 59.63 13.60 688 51116 678021 79014563
Post procedural haemorrhage 59.48 13.60 58 51746 13686 79678898
Mantle cell lymphoma 58.92 13.60 25 51779 1366 79691218
Infusion related reaction 58.26 13.60 39 51765 230198 79462386
Pericardial haemorrhage 57.36 13.60 36 51768 4459 79688125
Product use in unapproved indication 56.76 13.60 316 51488 250043 79442541
Hepatic enzyme increased 56.36 13.60 24 51780 182586 79509998
Brain abscess 54.28 13.60 36 51768 4900 79687684
Vasogenic cerebral oedema 53.98 13.60 24 51780 1469 79691115
Abdominal discomfort 53.95 13.60 50 51754 250677 79441907
Diffuse large B-cell lymphoma 53.95 13.60 52 51752 12097 79680487
White blood cell count abnormal 53.93 13.60 38 51766 5707 79686877
Chronic lymphocytic leukaemia transformation 52.13 13.60 15 51789 251 79692333
Therapy partial responder 51.49 13.60 60 51744 17337 79675247
Intentional overdose 50.76 13.60 5 51799 105955 79586629
Joint swelling 49.67 13.60 69 51735 288577 79404007
Glossodynia 49.18 13.60 5 51799 103332 79589252
Discomfort 48.61 13.60 11 51793 125606 79566978
Mantle cell lymphoma refractory 48.13 13.60 12 51792 112 79692472
Respiratory failure 46.20 13.60 236 51568 180675 79511909
Purpura 45.94 13.60 60 51744 19467 79673117
Swelling 45.70 13.60 44 51760 216667 79475917
Alopecia 45.36 13.60 50 51754 231305 79461279
Malaise 45.08 13.60 165 51639 489704 79202880
Squamous cell carcinoma 44.77 13.60 53 51751 15569 79677015
Capillary permeability increased 43.88 13.60 9 51795 30 79692554
Subdural haemorrhage 43.81 13.60 34 51770 5914 79686670
Progressive multifocal leukoencephalopathy 43.43 13.60 60 51744 20540 79672044
Prostatic operation 43.15 13.60 13 51791 257 79692327
Lymphocyte count decreased 43.01 13.60 95 51709 47194 79645390
Splenic rupture 42.91 13.60 24 51780 2405 79690179
Ear haemorrhage 42.76 13.60 23 51781 2134 79690450
Hyperuricaemia 42.33 13.60 45 51759 11754 79680830
Hyperphosphataemia 41.73 13.60 34 51770 6342 79686242
Asthma 41.29 13.60 18 51786 135077 79557507
Anxiety 41.17 13.60 61 51743 248451 79444133
Mobility decreased 41.12 13.60 14 51790 122161 79570423
Leukostasis syndrome 40.94 13.60 10 51794 85 79692499
Platelet count abnormal 40.70 13.60 30 51774 4832 79687752
Arrhythmia 40.66 13.60 109 51695 61163 79631421
Haematotympanum 40.16 13.60 8 51796 22 79692562
Muscle spasms 39.87 13.60 221 51583 174509 79518075
Pseudomonas infection 39.81 13.60 58 51746 20845 79671739
Loss of personal independence in daily activities 39.65 13.60 9 51795 102571 79590013
Intentional product misuse 39.60 13.60 7 51797 95158 79597426
Cytopenia 39.46 13.60 57 51747 20326 79672258
Urticaria 38.58 13.60 38 51766 185163 79507421
Wound 37.92 13.60 14 51790 116165 79576419
Blood urine present 37.56 13.60 57 51747 21240 79671344
Blood cholesterol increased 37.48 13.60 5 51799 83715 79608869
Haemorrhagic diathesis 36.81 13.60 31 51773 6053 79686531
Haemorrhage subcutaneous 36.54 13.60 28 51776 4781 79687803
Eye haemorrhage 36.41 13.60 38 51766 9719 79682865
Product use issue 36.26 13.60 247 51557 209575 79483009
Neurological symptom 36.03 13.60 36 51768 8747 79683837
Flushing 35.64 13.60 7 51797 88261 79604323
Wheezing 34.94 13.60 16 51788 116648 79575936
Haemolytic anaemia 34.74 13.60 50 51754 17770 79674814
Suicide attempt 34.73 13.60 6 51798 82926 79609658
Agitation 34.30 13.60 11 51793 99704 79592880
Sudden death 33.83 13.60 56 51748 22455 79670129
Cytokine release syndrome 33.51 13.60 73 51731 35925 79656659
Skin haemorrhage 33.27 13.60 40 51764 11941 79680643
Diarrhoea 33.10 13.60 776 51028 879713 78812871
Fungal abscess central nervous system 32.38 13.60 9 51795 132 79692452
Infective exacerbation of chronic obstructive airways disease 32.30 13.60 21 51783 2763 79689821
Blood pressure increased 32.05 13.60 55 51749 211305 79481279
Vomiting 31.88 13.60 278 51526 665550 79027034
Helicobacter infection 31.59 13.60 4 51800 69700 79622884
Abdominal pain 31.52 13.60 138 51666 389431 79303153
Paraesthesia 31.47 13.60 41 51763 176282 79516302
Scleroderma 31.14 13.60 27 51777 5483 79687101
Weight increased 30.67 13.60 86 51718 277300 79415284
Polymyositis 30.65 13.60 21 51783 3015 79689569
Psoriasis 30.61 13.60 10 51794 89577 79603007
Pruritus 30.61 13.60 142 51662 394506 79298078
Gastric haemorrhage 30.48 13.60 43 51761 15007 79677577
White blood cell count decreased 30.38 13.60 218 51586 188070 79504514
Lymphoma 29.76 13.60 46 51758 17414 79675170
Blood creatine phosphokinase increased 29.46 13.60 4 51800 66086 79626498
Depressed level of consciousness 29.34 13.60 13 51791 96639 79595945
Chronic graft versus host disease in skin 29.03 13.60 16 51788 1558 79691026
Pneumonia fungal 28.82 13.60 36 51768 11174 79681410
Abdominal lymphadenopathy 28.64 13.60 15 51789 1319 79691265
Iodine uptake abnormal 28.24 13.60 5 51799 5 79692579
Chronic graft versus host disease 28.20 13.60 28 51776 6753 79685831
Cryptococcosis 28 13.60 21 51783 3472 79689112
Gingival bleeding 27.91 13.60 43 51761 16233 79676351
Electrocardiogram QT prolonged 27.68 13.60 12 51792 90374 79602210
Bacterial pericarditis 27.64 13.60 7 51797 70 79692514
Cardiac tamponade 27.46 13.60 32 51772 9244 79683340
Laboratory test abnormal 27.39 13.60 58 51746 27990 79664594
Inguinal hernia 27.37 13.60 27 51777 6461 79686123
Blood lactate dehydrogenase increased 27.32 13.60 71 51733 39099 79653485
Suicidal ideation 27.01 13.60 8 51796 76332 79616252
Pyoderma gangrenosum 26.85 13.60 22 51782 4136 79688448
Erysipelas 26.56 13.60 34 51770 10816 79681768
Somnolence 26.48 13.60 74 51730 238907 79453677
Mucormycosis 26.39 13.60 30 51774 8439 79684145
Skin lesion 26.32 13.60 73 51731 41771 79650813
Hepatitis E 26.30 13.60 19 51785 2967 79689617
Haemoptysis 26.14 13.60 88 51716 55911 79636673
Anaemia 26.13 13.60 420 51384 444595 79247989
Pneumonitis 26.11 13.60 93 51711 60767 79631817
Anaphylactic reaction 25.84 13.60 11 51793 83732 79608852
Cystoid macular oedema 25.62 13.60 16 51788 1964 79690620
Subarachnoid haemorrhage 25.54 13.60 52 51752 24413 79668171
B-cell small lymphocytic lymphoma recurrent 25.30 13.60 5 51799 13 79692571
Irritable bowel syndrome 24.99 13.60 5 51799 62236 79630348
Hepatitis B reactivation 24.99 13.60 25 51779 6083 79686501
Blood pressure decreased 24.94 13.60 17 51787 99449 79593135
Lymphoma transformation 24.85 13.60 9 51795 321 79692263
Haemophagocytic lymphohistiocytosis 24.71 13.60 48 51756 21789 79670795
Migraine 24.68 13.60 13 51791 87480 79605104
Hypoglycaemia 24.63 13.60 18 51786 101576 79591008
Surgery 24.52 13.60 61 51743 32705 79659879
Therapy non-responder 24.20 13.60 15 51789 92290 79600294
Oxygen saturation decreased 24.08 13.60 29 51775 129018 79563566
Hospitalisation 24.08 13.60 123 51681 94113 79598471
Gout 23.96 13.60 51 51753 24698 79667886
Stress 23.71 13.60 11 51793 79601 79612983
Metabolic acidosis 23.67 13.60 12 51792 82517 79610067
Cardiomyopathy 23.06 13.60 55 51749 28719 79663865
Pneumocystis jirovecii pneumonia 22.75 13.60 59 51745 32449 79660135
Septic shock 22.67 13.60 147 51657 122654 79569930
International normalised ratio increased 21.89 13.60 14 51790 84707 79607877
Urinary tract infection 21.67 13.60 273 51531 274239 79418345
Ill-defined disorder 21.39 13.60 8 51796 65867 79626717
Splenic haemorrhage 21.28 13.60 10 51794 696 79691888
C-reactive protein increased 21.03 13.60 32 51772 128995 79563589
Biopsy 20.65 13.60 10 51794 744 79691840
Pulmonary mass 20.63 13.60 53 51751 28981 79663603
Nasopharyngitis 20.47 13.60 90 51714 253791 79438793
Infectious pleural effusion 20.46 13.60 18 51786 3726 79688858
Conjunctival haemorrhage 20.39 13.60 22 51782 5843 79686741
Bacteraemia 20.38 13.60 57 51747 32767 79659817
Immunodeficiency common variable 20.32 13.60 8 51796 360 79692224
Beta 2 microglobulin increased 20.20 13.60 8 51796 366 79692218
Hospice care 20.17 13.60 29 51775 10295 79682289
Erythema 19.98 13.60 76 51728 223214 79469370
Chronic lymphocytic leukaemia refractory 19.85 13.60 6 51798 120 79692464
Medication error 19.65 13.60 10 51794 68632 79623952
Therapeutic product effect incomplete 19.57 13.60 39 51765 141606 79550978
Meningitis cryptococcal 19.45 13.60 17 51787 3489 79689095
Skin cancer 19.44 13.60 35 51769 15005 79677579
Eye operation 19.30 13.60 14 51790 2199 79690385
Pneumonia pneumococcal 19.30 13.60 18 51786 4019 79688565
Mass 19.27 13.60 38 51766 17434 79675150
Full blood count abnormal 19.24 13.60 64 51740 40410 79652174
Gait disturbance 18.97 13.60 70 51734 207436 79485148
Blood pressure systolic increased 18.82 13.60 10 51794 66976 79625608
Procedural haemorrhage 18.77 13.60 19 51785 4687 79687897
Ureteric compression 18.66 13.60 7 51797 276 79692308
Vitreous haemorrhage 18.61 13.60 17 51787 3696 79688888
Cellulitis 18.59 13.60 128 51676 108932 79583652
Haemorrhagic disorder 18.55 13.60 12 51792 1566 79691018
Supraventricular tachycardia 18.52 13.60 42 51762 21228 79671356
Hypercalcaemia 18.48 13.60 61 51743 38369 79654215
Injury 18.44 13.60 14 51790 77482 79615102
Mantle cell lymphoma stage IV 18.34 13.60 5 51799 68 79692516
Plasma cell myeloma 18.09 13.60 6 51798 53253 79639331
Haemolysis 18.09 13.60 31 51773 12781 79679803
Cardiac failure congestive 18.07 13.60 156 51648 142246 79550338
Discouragement 18.06 13.60 12 51792 1638 79690946
Myositis 17.98 13.60 39 51765 19129 79673455
Meningitis enteroviral 17.89 13.60 5 51799 75 79692509
Heart rate decreased 17.65 13.60 12 51792 70304 79622280
Prostatectomy 17.46 13.60 6 51798 183 79692401
SARS-CoV-2 test positive 17.41 13.60 29 51775 11687 79680897
Hallucination 17.38 13.60 18 51786 85727 79606857
Encephalitis 17.38 13.60 33 51771 14727 79677857
Coma 17.35 13.60 24 51780 100625 79591959
Blood disorder 17.29 13.60 24 51780 8249 79684335
Headache 17.24 13.60 310 51494 653462 79039122
Tremor 17.15 13.60 55 51749 170028 79522556
Syncope 17.06 13.60 185 51619 179264 79513320
Toxic epidermal necrolysis 17.05 13.60 4 51800 44577 79648007
Bone marrow transplant 16.99 13.60 11 51793 1437 79691147
Pulmonary embolism 16.97 13.60 56 51748 171598 79520986
Pneumonia pseudomonal 16.85 13.60 20 51784 5891 79686693
Wrong technique in product usage process 16.76 13.60 14 51790 73861 79618723
Uveitis 16.66 13.60 35 51769 16795 79675789
Angina bullosa haemorrhagica 16.54 13.60 6 51798 215 79692369
Angioedema 16.53 13.60 15 51789 76020 79616564
Cataract 16.51 13.60 82 51722 62038 79630546
Arteriosclerotic retinopathy 16.48 13.60 4 51800 33 79692551
Confusional state 16.43 13.60 130 51674 317867 79374717
Pneumonia cryptococcal 16.41 13.60 11 51793 1524 79691060
Rhabdomyolysis 16.40 13.60 26 51778 103105 79589479
Pallor 16.39 13.60 6 51798 50056 79642528
Cytomegalovirus infection reactivation 16.33 13.60 24 51780 8692 79683892
Sleep disorder 16.25 13.60 19 51785 85658 79606926
Transurethral prostatectomy 16.18 13.60 6 51798 229 79692355
Papilloma excision 16.08 13.60 3 51801 5 79692579
Graft versus host disease in lung 16.08 13.60 9 51795 903 79691681
Heart rate increased 16.03 13.60 34 51770 120690 79571894
Soft tissue infection 15.98 13.60 16 51788 3896 79688688
Hypertensive crisis 15.89 13.60 39 51765 20731 79671853
Depressed mood 15.85 13.60 68 51736 48412 79644172
Haemorrhage urinary tract 15.85 13.60 13 51791 2448 79690136
Muscle haemorrhage 15.83 13.60 20 51784 6280 79686304
Hyperviscosity syndrome 15.78 13.60 7 51797 426 79692158
Product use complaint 15.74 13.60 13 51791 2470 79690114
Pseudohyperkalaemia 15.73 13.60 3 51801 6 79692578
Non-small cell lung cancer 15.68 13.60 20 51784 6340 79686244
Eosinophilia 15.60 13.60 5 51799 45340 79647244
Blister 15.57 13.60 34 51770 119442 79573142
B-cell small lymphocytic lymphoma 15.57 13.60 5 51799 123 79692461
Dyspnoea 15.56 13.60 431 51373 856594 78835990
Pneumonia bacterial 15.55 13.60 37 51767 19294 79673290
Central nervous system fungal infection 15.38 13.60 7 51797 453 79692131
Injection site bruising 15.06 13.60 4 51800 40998 79651586
Bradycardia 14.99 13.60 42 51762 135515 79557069
Gastrointestinal disorder 14.94 13.60 36 51768 122169 79570415
Cardiac disorder 14.86 13.60 83 51721 65674 79626910
Chronic graft versus host disease in eye 14.66 13.60 5 51799 149 79692435
Scrotal haematocoele 14.63 13.60 3 51801 10 79692574
Renal impairment 14.57 13.60 53 51751 157730 79534854
Restlessness 14.51 13.60 6 51798 46486 79646098
Abdominal pain upper 14.27 13.60 86 51718 223733 79468851
Supportive care 14.20 13.60 3 51801 12 79692572
Alanine aminotransferase increased 14.11 13.60 56 51748 162514 79530070
Haemoglobin abnormal 14.06 13.60 20 51784 7034 79685550
Lymph node palpable 14.01 13.60 5 51799 171 79692413
Type 2 diabetes mellitus 14.00 13.60 10 51794 57112 79635472
Pancytopenia 14.00 13.60 167 51637 165578 79527006
Benign prostatic hyperplasia 13.72 13.60 26 51778 11586 79680998
Squamous cell carcinoma of skin 13.68 13.60 29 51775 14004 79678580
Mouth haemorrhage 13.62 13.60 25 51779 10874 79681710

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EL01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Bruton's tyrosine kinase (BTK) inhibitors
FDA MoA N0000175076 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:76617 BTK inhibitor

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Waldenström macroglobulinemia indication 190818004 DOID:0050747
Malignant lymphoma - small lymphocytic indication 302841002
M lymphoplasmacytic indication 307623001
Chronic graft-versus-host disease indication 402356004
Mantle cell lymphoma indication 443487006
Marginal zone lymphoma indication 447100004
Pregnancy, function contraindication 289908002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8476284 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8497277 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8703780 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8952015 Dec. 28, 2026 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8563563 April 26, 2027 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8563563 April 26, 2027 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8563563 April 26, 2027 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9125889 June 3, 2031 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC 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 LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
280MG IMBRUVICA PHARMACYCLICS LLC 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 LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 11672803 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
420MG IMBRUVICA PHARMACYCLICS LLC 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 LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10004746 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10004746 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10016435 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10478439 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10653696 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10751342 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10751342 June 3, 2031 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10751342 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8754090 June 3, 2031 TREATMENT OF MANTLE CELL LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8999999 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 8999999 June 3, 2031 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9125889 June 3, 2031 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9801881 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9801883 June 3, 2031 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9814721 June 3, 2031 TREATMENT OF MARGINAL ZONE LYMPHOMA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MANTLE CELL LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MARGINAL ZONE LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF MANTLE CELL LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9540382 Aug. 18, 2033 TREATMENT OF WALDENSTROMS MACROGLOBULINEMIA
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10463668 Oct. 24, 2034 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 10695350 Oct. 24, 2034 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL 9795604 Oct. 24, 2034 TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9795604 Oct. 24, 2034 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
140MG IMBRUVICA PHARMACYCLICS LLC 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)
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL March 4, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL March 4, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL March 4, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL March 4, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL March 4, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL May 6, 2023 FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL May 6, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL May 6, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL May 6, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL May 6, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL May 6, 2023 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Aug. 2, 2024 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL Aug. 2, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 2, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 2, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 2, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL Aug. 2, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Feb. 2, 2025 PEDIATRIC EXCLUSIVITY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Aug. 24, 2025 NEW PATIENT POPULATION
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL Aug. 24, 2025 NEW PATIENT POPULATION
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2025 NEW PATIENT POPULATION
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2025 NEW PATIENT POPULATION
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2025 NEW PATIENT POPULATION
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL Aug. 24, 2025 NEW PATIENT POPULATION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL Aug. 24, 2025 NEW PRODUCT
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL Feb. 24, 2026 PEDIATRIC EXCLUSIVITY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL Aug. 24, 2029 TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
140MG IMBRUVICA PHARMACYCLICS LLC N205552 Nov. 13, 2013 RX CAPSULE ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
70MG IMBRUVICA PHARMACYCLICS LLC N205552 Dec. 20, 2017 RX CAPSULE ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
140MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
280MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
420MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 RX TABLET ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
560MG IMBRUVICA PHARMACYCLICS LLC N210563 Feb. 16, 2018 DISCN TABLET ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL Feb. 24, 2030 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

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 ABL1 Kinase IC50 7.07 CHEMBL
Epidermal growth factor receptor Kinase IC50 8.25 CHEMBL
Breakpoint cluster region protein Kinase Kd 5.84 CHEMBL
Receptor-type tyrosine-protein kinase FLT3 Kinase Kd 5.80 CHEMBL
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 7.43 CHEMBL
Macrophage colony-stimulating factor 1 receptor Kinase IC50 5.26 CHEMBL
Tyrosine-protein kinase CSK Kinase IC50 8.66 CHEMBL
Cytoplasmic tyrosine-protein kinase BMX Kinase IC50 9.10 CHEMBL
LIM domain kinase 1 Kinase Kd 4.68 CHEMBL
Tyrosine-protein kinase Fer Kinase IC50 5.09 CHEMBL
Abelson tyrosine-protein kinase 2 Kinase Kd 6.04 CHEMBL
Fibroblast growth factor receptor 2 Kinase IC50 6.55 CHEMBL
Tyrosine-protein kinase FRK Kinase Kd 6.23 CHEMBL
Receptor-interacting serine/threonine-protein kinase 2 Kinase Kd 7.24 CHEMBL
Protein-tyrosine kinase 6 Kinase IC50 8.48 CHEMBL
Mitogen-activated protein kinase kinase kinase MLT Kinase Kd 5.77 CHEMBL
Serine/threonine-protein kinase LATS1 Kinase Kd 5.72 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5 Kinase Kd 6.61 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel Ki 5.96 CHEMBL
Platelet glycoprotein VI Unclassified IC50 6.92 CHEMBL
Receptor-interacting serine/threonine-protein kinase 3 Kinase Kd 7.07 CHEMBL
Nuclear receptor subfamily 4 group A member 3 Nuclear other IC50 7.11 CHEMBL
Tyrosine-protein kinase Lyn Kinase Ki 7.85 SCIENTIFIC LITERATURE
Tyrosine-protein kinase JAK3 Kinase INHIBITOR IC50 7.50 SCIENTIFIC LITERATURE
Proto-oncogene tyrosine-protein kinase Src Kinase INHIBITOR IC50 7.72 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Lck Kinase INHIBITOR IC50 8.20 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Yes Kinase INHIBITOR IC50 8.39 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Fyn Kinase INHIBITOR IC50 7.54 SCIENTIFIC LITERATURE
Receptor tyrosine-protein kinase erbB-2 Kinase INHIBITOR IC50 8.19 SCIENTIFIC LITERATURE
Tyrosine-protein kinase HCK Kinase INHIBITOR IC50 7.54 SCIENTIFIC LITERATURE
Receptor tyrosine-protein kinase erbB-4 Kinase INHIBITOR IC50 8.47 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Fgr Kinase INHIBITOR IC50 8.48 SCIENTIFIC LITERATURE
Tyrosine-protein kinase ITK/TSK Kinase INHIBITOR IC50 8.31 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Tec Kinase INHIBITOR IC50 8.16 SCIENTIFIC LITERATURE
Tyrosine-protein kinase TXK Kinase INHIBITOR IC50 8.70 SCIENTIFIC LITERATURE
Tyrosine-protein kinase Blk Kinase INHIBITOR IC50 10 SCIENTIFIC LITERATURE
Redox-regulatory protein FAM213A Unclassified IC50 6.05 CHEMBL

External reference:

IDSource
D10223 KEGG_DRUG
4032872 VANDF
CHEBI:76612 CHEBI
1E8 PDB_CHEM_ID
CHEMBL1873475 ChEMBL_ID
C551803 MESH_SUPPLEMENTAL_RECORD_UI
6912 IUPHAR_LIGAND_ID
9566 INN_ID
DB09053 DRUGBANK_ID
1X70OSD4VX UNII
1442981 RXNORM
207254 MMSL
29840 MMSL
d08170 MMSL
015287 NDDF
710228002 SNOMEDCT_US
715598009 SNOMEDCT_US
C3501358 UMLSCUI
24821094 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-007 SUSPENSION 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-007 SUSPENSION 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-007 SUSPENSION 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-014 TABLET, FILM COATED 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-014 TABLET, FILM COATED 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-014 TABLET, FILM COATED 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-014 TABLET, FILM COATED 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-070 CAPSULE 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-070 CAPSULE 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-070 CAPSULE 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-070 CAPSULE 70 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-140 CAPSULE 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-140 CAPSULE 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-140 CAPSULE 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-140 CAPSULE 140 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-280 TABLET, FILM COATED 280 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-280 TABLET, FILM COATED 280 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-280 TABLET, FILM COATED 280 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-280 TABLET, FILM COATED 280 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-420 TABLET, FILM COATED 420 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-420 TABLET, FILM COATED 420 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-420 TABLET, FILM COATED 420 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-420 TABLET, FILM COATED 420 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-560 TABLET, FILM COATED 560 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-560 TABLET, FILM COATED 560 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-560 TABLET, FILM COATED 560 mg ORAL NDA 32 sections
Imbruvica HUMAN PRESCRIPTION DRUG LABEL 1 57962-560 TABLET, FILM COATED 560 mg ORAL NDA 32 sections