ibrutinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.922 Moderate 0.77
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.803 Moderate 0.77
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 55.590 10^-6 cm/s Moderate 0.77
dh-clint Dog hepatocyte intrinsic clearance 72.444 uL/min/10^6 cells Moderate 0.77
dppb Dog plasma protein binding (% unbound) 2.560 % Moderate 0.77
fcs-ppb Fetal calf serum protein binding (% unbound) 4.910 % Moderate 0.77
herg hERG pIC50 5.091 pIC50 Moderate 0.77
hh-clint Human hepatocyte intrinsic clearance 144.212 uL/min/10^6 cells Moderate 0.77
hlm-clint Human liver microsomal intrinsic clearance 298.538 uL/min/mg protein Moderate 0.77
hppb Human plasma protein binding (% unbound) 1.840 % Moderate 0.77
kinase-safety-class ABL1,ABL2,ACVR2B,AURKA,BLK,BMX,BTK,CAMK2D,CSF1R,CSK,DDR1,EGFR,EIF2AK3,EPHA2,ERBB2,ERBB4,FGFR1,FYN,GAK,ITK,JAK3,KDR,LCK,LYN,MAP4K5,MAPK10,MINK1,NTRK1,PDK1,PDK2,PDK4,PTK6,RET,RIPK3,SRC,STK33,YES1 37
kinase-selectivity-class ABL2,ACVR2B,ACVRL1,AURKA,AXL,BLK,BMX,BTK,CSF1R,CSK,EGFR,ERBB2,ERBB4,FLT3,FLT4,FYN,JAK3,KDR,LCK,LYN,MAP2K1,MAP3K21,MINK1,PDK4,PIK3CD,RET,RIPK3,SIK2,SRC,TGFBR1,YES1 31
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.542 Moderate 0.76
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.565 Moderate 0.77
mh-clint Mouse hepatocyte intrinsic clearance 298.538 Moderate 0.77
mppb Mouse plasma protein binding (% unbound) 2.010 Moderate 0.77
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 11.967 Moderate 0.77
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 2.860 % Moderate 0.77
rat-kpuu-brain Rat brain Kpuu 0.209 % Moderate 0.76
rh-clint Rat hepatocyte intrinsic clearance 301.995 uL/min/10^6 cells Moderate 0.77
rh-fuinc Rat hepatocyte fraction unbound in incubation 17.750 % Moderate 0.77
rppb Rat plasma protein binding (% unbound) 2.190 % Moderate 0.77
solubility-dd Solubility at pH 7.4 in DMSO 10.544 uM Moderate 0.77

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 1129.70 17.05 976 25008 455575 90146888
Atrial fibrillation 530.18 17.05 379 25605 133232 90469231
Disease progression 350.85 17.05 318 25666 156297 90446166
Off label use 339.30 17.05 876 25108 1101376 89501087
Incorrect dose administered 256.86 17.05 199 25785 78731 90523732
Hospice care 174.95 17.05 75 25909 9629 90592834
Petechiae 166.24 17.05 84 25900 15657 90586806
Lymphadenopathy 161.13 17.05 121 25863 45654 90556809
Lymphocytosis 150.04 17.05 49 25935 2948 90599515
Platelet count decreased 142.97 17.05 186 25798 136783 90465680
White blood cell count increased 131.92 17.05 127 25857 67114 90535349
Pleural effusion 121.42 17.05 155 25829 111836 90490627
Pericardial effusion 115.68 17.05 91 25893 36742 90565721
Haematoma 115.21 17.05 93 25891 38955 90563508
Tumour lysis syndrome 113.35 17.05 58 25926 11094 90591369
Aspergillus infection 112.07 17.05 57 25927 10766 90591697
Contusion 107.23 17.05 228 25756 250988 90351475
Onychoclasis 107.01 17.05 49 25935 7350 90595113
Epistaxis 103.79 17.05 125 25859 85000 90517463
Thrombocytopenia 102.76 17.05 201 25783 208524 90393939
Haemorrhage 98.18 17.05 110 25874 69259 90533204
Vasogenic cerebral oedema 97.88 17.05 29 25955 1261 90601202
Ecchymosis 96.83 17.05 54 25930 12269 90590194
Drug hypersensitivity 94.80 17.05 11 25973 463598 90138865
Cytopenia 94.12 17.05 60 25924 17389 90585074
Neutropenia 93.51 17.05 202 25782 224702 90377761
Diffuse large B-cell lymphoma recurrent 90.09 17.05 35 25949 3491 90598972
Chronic lymphocytic leukaemia recurrent 88.59 17.05 21 25963 378 90602085
Lymphoma 86.68 17.05 52 25932 13539 90588924
Arthropathy 84.98 17.05 5 25979 366237 90236226
Infusion related reaction 84.92 17.05 10 25974 416770 90185693
Lymphocyte count increased 81.93 17.05 34 25950 4025 90598438
Subdural haematoma 81.83 17.05 54 25930 16591 90585872
Rheumatoid arthritis 81.04 17.05 6 25978 362608 90239855
Cerebral haemorrhage 80.85 17.05 72 25912 34450 90568013
Mantle cell lymphoma recurrent 77.84 17.05 19 25965 389 90602074
COVID-19 77.54 17.05 158 25826 168685 90433778
Diffuse large B-cell lymphoma 76.55 17.05 41 25943 8604 90593859
Haemorrhage intracranial 76.51 17.05 50 25934 15112 90587351
Progressive multifocal leukoencephalopathy 70.27 17.05 48 25936 15607 90586856
Contraindicated product administered 69.56 17.05 6 25978 320133 90282330
Urinary tract infection 69.56 17.05 219 25765 305413 90297050
Leukocytosis 69.34 17.05 63 25921 30927 90571536
Neurological symptom 67.81 17.05 35 25949 6812 90595651
Pain 66.59 17.05 115 25869 996226 89606237
Hepatic enzyme increased 63.62 17.05 13 25971 360723 90241740
Condition aggravated 63.41 17.05 47 25937 595498 90006965
Hospitalisation 60.13 17.05 121 25863 127979 90474484
Hypogammaglobulinaemia 58.30 17.05 37 25947 10637 90591826
Pneumonia 57.96 17.05 346 25638 637713 89964750
Wound 57.58 17.05 9 25975 302971 90299492
Febrile neutropenia 56.58 17.05 134 25850 158215 90444248
Abdominal discomfort 55.71 17.05 34 25950 477294 90125169
Haemoglobin decreased 55.66 17.05 135 25849 161821 90440642
Chronic lymphocytic leukaemia 55.49 17.05 24 25960 3146 90599317
Neutrophil count decreased 55.02 17.05 84 25900 71448 90531015
Increased tendency to bruise 54.66 17.05 37 25947 11853 90590610
Helicobacter infection 52.89 17.05 3 25981 226847 90375616
Cerebral aspergillosis 52.83 17.05 15 25969 560 90601903
Sepsis 52.57 17.05 141 25843 179673 90422790
Splenomegaly 51.87 17.05 37 25947 12887 90589576
Joint swelling 50.67 17.05 42 25942 503258 90099205
Discomfort 50.24 17.05 9 25975 274326 90328137
Drug ineffective 49.51 17.05 217 25767 1384081 89218382
Campylobacter infection 49.49 17.05 17 25967 1195 90601268
Therapeutic product effect decreased 48.93 17.05 10 25974 277561 90324902
Folliculitis 46.73 17.05 3 25981 204350 90398113
Swelling 45.96 17.05 32 25952 419026 90183437
Musculoskeletal stiffness 45.86 17.05 14 25970 296518 90305945
Therapy partial responder 45.80 17.05 43 25941 22000 90580463
Capillary permeability increased 45.69 17.05 8 25976 26 90602437
Wheezing 45.39 17.05 7 25977 238073 90364390
Autoimmune haemolytic anaemia 45.06 17.05 25 25959 5620 90596843
Blood cholesterol increased 44.89 17.05 4 25980 208008 90394455
Hypersensitivity 44.46 17.05 39 25945 454638 90147825
Asthma 44.22 17.05 8 25976 242152 90360311
Anaemia 44.05 17.05 209 25775 352593 90249870
Septic shock 42.50 17.05 82 25902 84078 90518385
Irritable bowel syndrome 42.15 17.05 5 25979 207443 90395020
Diarrhoea 41.04 17.05 430 25554 938760 89663703
Cytokine release syndrome 40.66 17.05 45 25939 27928 90574535
Mobility decreased 40.31 17.05 11 25973 250723 90351740
Bronchopulmonary aspergillosis 39.79 17.05 30 25954 11368 90591095
Urticaria 39.75 17.05 20 25964 312714 90289749
Haematotympanum 38.79 17.05 6 25978 6 90602457
Blister 37.73 17.05 13 25971 254985 90347478
Injury 37.17 17.05 6 25978 197343 90405120
Uveitis 36.89 17.05 33 25951 15870 90586593
Impaired healing 36.31 17.05 11 25973 234188 90368275
Eye haemorrhage 36.00 17.05 27 25957 10153 90592310
Blood blister 35.99 17.05 16 25968 2239 90600224
Haematuria 34.16 17.05 46 25938 34891 90567572
Ill-defined disorder 33.98 17.05 6 25978 184885 90417578
Anal squamous cell carcinoma 33.87 17.05 11 25973 650 90601813
Pancytopenia 33.82 17.05 93 25891 120170 90482293
Hyperuricaemia 33.51 17.05 22 25962 6697 90595766
Skin toxicity 33.33 17.05 22 25962 6757 90595706
Migraine 33.25 17.05 7 25977 190385 90412078
COVID-19 pneumonia 33.13 17.05 33 25951 18144 90584319
Spinal fracture 33.01 17.05 36 25948 21980 90580483
Purpura 32.97 17.05 30 25954 14748 90587715
Type 2 diabetes mellitus 32.51 17.05 9 25975 203235 90399228
Alopecia 32.17 17.05 58 25926 495013 90107450
Fall 32.03 17.05 242 25742 481568 90120895
Psoriasis 31.45 17.05 3 25981 147751 90454712
Non-small cell lung cancer 31.18 17.05 18 25966 4363 90598100
Completed suicide 30.73 17.05 3 25981 145055 90457408
Discouragement 30.65 17.05 13 25971 1624 90600839
Cardiac failure 30.12 17.05 84 25900 109412 90493051
Chronic lymphocytic leukaemia refractory 30.12 17.05 6 25978 45 90602418
Pericardial haemorrhage 28.95 17.05 13 25971 1863 90600600
Urosepsis 28.88 17.05 33 25951 21199 90581264
Haemothorax 28.77 17.05 14 25970 2404 90600059
Drug intolerance 28.57 17.05 53 25931 447538 90154925
Chronic lymphocytic leukaemia transformation 28.31 17.05 6 25978 63 90602400
Cystoid macular oedema 27.55 17.05 13 25971 2087 90600376
Malignant neoplasm progression 27.46 17.05 80 25904 106790 90495673
Hypercalcaemia 27.44 17.05 41 25943 34199 90568264
Stem cell transplant 27.23 17.05 13 25971 2141 90600322
Abdominal mass 26.49 17.05 15 25969 3506 90598957
Product use complaint 26.45 17.05 15 25969 3518 90598945
Sleep disorder 26.17 17.05 12 25972 198018 90404445
Splenic rupture 26.04 17.05 11 25973 1360 90601103
Clostridium difficile colitis 25.86 17.05 35 25949 26671 90575792
Pneumonia fungal 25.65 17.05 19 25965 7012 90595451
Weight increased 25.35 17.05 51 25933 417876 90184587
Blood lactate dehydrogenase increased 25.13 17.05 34 25950 25898 90576565
Haemorrhagic diathesis 24.94 17.05 17 25967 5507 90596956
Cardiac tamponade 24.64 17.05 17 25967 5615 90596848
Ear haemorrhage 24.44 17.05 11 25973 1585 90600878
Splenic haematoma 24.44 17.05 6 25978 126 90602337
Atrial flutter 24.31 17.05 22 25962 10736 90591727
Immune effector cell-associated neurotoxicity syndrome 24.27 17.05 17 25967 5751 90596712
Chronic graft versus host disease 24.24 17.05 15 25969 4124 90598339
Full blood count abnormal 24.04 17.05 40 25944 36557 90565906
Cytomegalovirus infection reactivation 23.89 17.05 19 25965 7781 90594682
Cardiac disorder 23.49 17.05 51 25933 56821 90545642
Hyperphosphataemia 23.15 17.05 14 25970 3697 90598766
Neutropenic infection 23.12 17.05 11 25973 1798 90600665
Muscle spasms 23.02 17.05 137 25847 251746 90350717
Pruritus 23.00 17.05 79 25905 541446 90061017
Meningitis cryptococcal 22.98 17.05 11 25973 1822 90600641
Hip fracture 22.87 17.05 37 25947 33040 90569423
White blood cell count abnormal 22.39 17.05 18 25966 7486 90594977
Panniculitis 22.30 17.05 24 25960 14434 90588029
Sudden death 22.12 17.05 21 25963 10888 90591575
Disseminated mucormycosis 22.02 17.05 8 25976 663 90601800
Oligospermia 21.47 17.05 3 25981 0 90602463
Pyrexia 21.47 17.05 286 25698 660199 89942264
Breast haematoma 21.45 17.05 6 25978 212 90602251
Bacteraemia 21.25 17.05 29 25955 22271 90580192
Adenocarcinoma of colon 21.24 17.05 12 25972 2794 90599669
Cavernous sinus thrombosis 20.95 17.05 6 25978 231 90602232
Surgery 20.56 17.05 42 25942 44845 90557618
Myalgia 20.56 17.05 102 25882 175023 90427440
White blood cell count decreased 20.09 17.05 98 25886 167011 90435452
Liver injury 20.07 17.05 12 25972 170555 90431908
Respiratory failure 20.04 17.05 77 25907 118341 90484122
Chemotherapy 20.02 17.05 10 25974 1817 90600646
Arrhythmia 19.86 17.05 40 25944 42292 90560171
Syncope 19.84 17.05 83 25901 132580 90469883
Therapeutic product effect incomplete 19.70 17.05 16 25968 193880 90408583
Acidosis hyperchloraemic 19.68 17.05 8 25976 898 90601565
Nasopharyngitis 19.66 17.05 56 25928 407048 90195415
Deafness 19.55 17.05 28 25956 22486 90579977
Treatment failure 19.37 17.05 36 25948 303892 90298571
Lip dry 19.16 17.05 3 25981 100952 90501511
Lymphocyte count decreased 18.74 17.05 35 25949 35015 90567448
Nonspecific reaction 18.57 17.05 11 25973 2798 90599665
Injection site erythema 18.53 17.05 3 25981 98499 90503964
Paraesthesia 18.41 17.05 27 25957 250299 90352164
C-reactive protein increased 18.38 17.05 15 25969 181374 90421089
Loss of personal independence in daily activities 18.36 17.05 8 25976 136097 90466366
Skin lesion 18.36 17.05 36 25948 37329 90565134
Gingival bleeding 18.33 17.05 22 25962 14881 90587582
Iridocyclitis 18.29 17.05 12 25972 3649 90598814
Mantle cell lymphoma 18.27 17.05 7 25977 672 90601791
Obesity 18.17 17.05 4 25980 105503 90496960
Anxiety 17.77 17.05 39 25945 309733 90292730
Agranulocytosis 17.54 17.05 34 25950 34968 90567495
Morphoea 17.43 17.05 6 25978 424 90602039
Overdose 17.32 17.05 12 25972 157697 90444766
Confusional state 17.30 17.05 55 25929 386150 90216313
Leukostasis syndrome 17.14 17.05 4 25980 67 90602396

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 1109.44 13.69 1942 46724 469243 42103426
Atrial fibrillation 909.92 13.69 949 47717 138644 42434025
Disease progression 377.29 13.69 625 48041 143031 42429638
Incorrect dose administered 306.58 13.69 339 48327 52635 42520034
Lymphocytosis 294.99 13.69 116 48550 2915 42569754
Off label use 287.32 13.69 1458 47208 636877 41935792
Lymphadenopathy 266.47 13.69 254 48412 33111 42539558
Contusion 239.96 13.69 267 48399 41718 42530951
Lymphocyte count increased 227.26 13.69 105 48561 3959 42568710
Haemorrhage 212.89 13.69 302 48364 60261 42512408
Mantle cell lymphoma recurrent 181.49 13.69 61 48605 962 42571707
White blood cell count increased 175.17 13.69 236 48430 44851 42527818
Pleural effusion 167.12 13.69 353 48313 96813 42475856
Haematoma 142.78 13.69 168 48498 27855 42544814
Pneumonia 140.78 13.69 892 47774 421257 42151412
Platelet count decreased 137.33 13.69 408 48258 138173 42434496
Cerebral aspergillosis 135.18 13.69 57 48609 1720 42570949
Bronchopulmonary aspergillosis 129.31 13.69 134 48532 19295 42553374
Toxicity to various agents 121.30 13.69 55 48611 229081 42343588
Subdural haematoma 118.34 13.69 139 48527 22999 42549670
Hospice care 113.46 13.69 87 48579 8426 42564243
Tumour lysis syndrome 112.78 13.69 133 48533 22098 42550571
Petechiae 108.03 13.69 92 48574 10343 42562326
Pericardial effusion 104.28 13.69 147 48519 29128 42543541
Hypogammaglobulinaemia 101.52 13.69 94 48572 11797 42560872
Chronic lymphocytic leukaemia recurrent 95.88 13.69 34 48632 634 42572035
Splenomegaly 94.90 13.69 107 48559 16940 42555729
Completed suicide 93 13.69 4 48662 96461 42476208
Chronic lymphocytic leukaemia 86.39 13.69 59 48607 4770 42567899
Microsporidia infection 84.47 13.69 36 48630 1116 42571553
Haemothorax 84.38 13.69 60 48606 5176 42567493
Atrial flutter 83.86 13.69 101 48565 17150 42555519
Basal cell carcinoma 83.71 13.69 116 48550 22617 42550052
Autoimmune haemolytic anaemia 82.32 13.69 61 48605 5610 42567059
COVID-19 80.57 13.69 303 48363 115645 42457024
Aspergillus infection 77.44 13.69 93 48573 15744 42556925
Increased tendency to bruise 74.89 13.69 52 48614 4318 42568351
Condition aggravated 74.64 13.69 114 48552 260640 42312029
Product use issue 74.04 13.69 224 48442 76527 42496142
Epistaxis 70.15 13.69 201 48465 66625 42506044
Scleroderma 63.86 13.69 34 48632 1744 42570925
Drug ineffective 63.46 13.69 441 48225 629756 41942913
Mantle cell lymphoma 63.41 13.69 32 48634 1468 42571201
Overdose 62.66 13.69 21 48645 105243 42467426
Surgery 60.57 13.69 87 48579 17529 42555140
Cerebral haemorrhage 60.54 13.69 136 48530 38830 42533839
Ecchymosis 59.91 13.69 58 48608 7694 42564975
Polymyositis 58.37 13.69 32 48634 1741 42570928
Hospitalisation 53.05 13.69 196 48470 74134 42498535
Post procedural haemorrhage 52.76 13.69 59 48607 9253 42563416
Vomiting 52.73 13.69 163 48503 289560 42283109
Prostatic operation 51.90 13.69 20 48646 475 42572194
Injection site pain 50.82 13.69 4 48662 57794 42514875
Somnolence 50.43 13.69 52 48614 141053 42431616
Cytokine release syndrome 49.72 13.69 137 48529 44390 42528279
Neutropenia 47.29 13.69 389 48277 199042 42373627
Cardiac failure 47.27 13.69 244 48422 106612 42466057
Subdural haemorrhage 47.13 13.69 36 48630 3465 42569204
Haemoglobin decreased 46.99 13.69 285 48381 132186 42440483
Mantle cell lymphoma refractory 46.87 13.69 13 48653 102 42572567
Chronic graft versus host disease 46.41 13.69 45 48621 5980 42566689
Chronic lymphocytic leukaemia transformation 46.20 13.69 15 48651 211 42572458
Hepatitis E 46.14 13.69 34 48632 3100 42569569
COVID-19 pneumonia 46.08 13.69 86 48580 21527 42551142
Pericarditis 45.64 13.69 66 48600 13378 42559291
Agitation 45.59 13.69 9 48657 64305 42508364
Haematuria 45.15 13.69 157 48509 57642 42515027
Intentional overdose 44.04 13.69 4 48662 51452 42521217
Intentional product misuse 43.17 13.69 9 48657 61891 42510778
Thrombocytopenia 42.37 13.69 366 48300 189913 42382756
White blood cell count abnormal 40.94 13.69 34 48632 3691 42568978
Blood creatine phosphokinase increased 40.72 13.69 4 48662 48334 42524335
Pericardial haemorrhage 40.11 13.69 33 48633 3536 42569133
Plasma cell myeloma 39.92 13.69 4 48662 47574 42525095
Haemorrhage subcutaneous 39.62 13.69 29 48637 2617 42570052
Neutrophil count decreased 39.34 13.69 160 48506 63255 42509414
Blood immunoglobulin M increased 39.33 13.69 14 48652 264 42572405
Haemorrhagic diathesis 39.04 13.69 31 48635 3158 42569511
Pruritus 38.88 13.69 100 48566 188671 42383998
Leukocytosis 38.88 13.69 97 48569 29611 42543058
Cystoid macular oedema 37.80 13.69 20 48646 1013 42571656
Anxiety 37.69 13.69 48 48618 118512 42454157
Bone marrow transplant 37.55 13.69 21 48645 1188 42571481
Blood blister 37.46 13.69 26 48640 2157 42570512
Pseudomonas infection 37.30 13.69 66 48600 15857 42556812
Metabolic acidosis 37.29 13.69 7 48659 51851 42520818
Malignant syphilis 37.15 13.69 9 48657 38 42572631
Lymphocyte count decreased 36.60 13.69 91 48575 27718 42544951
Splenic rupture 36.48 13.69 23 48643 1624 42571045
Arrhythmia 36.37 13.69 115 48551 40202 42532467
Drug hypersensitivity 36.21 13.69 36 48630 99353 42473316
Wheezing 36.13 13.69 9 48657 54772 42517897
Suicide attempt 35.89 13.69 5 48661 46095 42526574
Nausea 35.79 13.69 286 48380 396513 42176156
Onychoclasis 35.11 13.69 27 48639 2625 42570044
Febrile neutropenia 34.19 13.69 343 48323 185360 42387309
Suicidal ideation 33.59 13.69 7 48659 48154 42524515
Pulmonary embolism 33.48 13.69 53 48613 119559 42453110
Electrocardiogram QT prolonged 33.37 13.69 7 48659 47938 42524731
Blood urine present 33.30 13.69 53 48613 11680 42560989
Squamous cell carcinoma 33.27 13.69 56 48610 12926 42559743
Uveitis 32.23 13.69 46 48620 9212 42563457
Abdominal lymphadenopathy 31.98 13.69 18 48648 1031 42571638
Musculoskeletal stiffness 31.87 13.69 13 48653 57752 42514917
Stress 31.72 13.69 6 48660 44206 42528463
Haematotympanum 31.60 13.69 6 48660 4 42572665
Depressed level of consciousness 31.41 13.69 8 48658 47962 42524707
Loss of personal independence in daily activities 31.31 13.69 9 48657 49807 42522862
Asthma 31.31 13.69 16 48650 62298 42510371
Haemolytic anaemia 30.67 13.69 52 48614 12075 42560594
Chemotherapy 30.59 13.69 16 48650 791 42571878
Haemorrhage intracranial 30.11 13.69 63 48603 17129 42555540
Angina bullosa haemorrhagica 30.02 13.69 8 48658 53 42572616
Rhabdomyolysis 29.89 13.69 27 48639 77992 42494677
Cardiac tamponade 29.69 13.69 37 48629 6503 42566166
Campylobacter infection 29.45 13.69 19 48647 1396 42571273
Hypoglycaemia 29.14 13.69 16 48650 59838 42512831
Herpes zoster 28.97 13.69 104 48562 38773 42533896
Diffuse large B-cell lymphoma 28.63 13.69 44 48622 9410 42563259
Stem cell transplant 28.56 13.69 24 48642 2648 42570021
Psoriasis 28.38 13.69 10 48656 48594 42524075
Transplant 28.08 13.69 16 48650 938 42571731
Blood pressure decreased 27.81 13.69 16 48650 58316 42514353
Platelet count abnormal 27.63 13.69 27 48639 3622 42569047
Brain abscess 27.51 13.69 29 48637 4255 42568414
Hypotension 27.39 13.69 177 48489 257454 42315215
Hallucination 27.10 13.69 16 48650 57491 42515178
Mass 26.93 13.69 41 48625 8698 42563971
Sudden death 26.90 13.69 59 48607 16570 42556099
Blood pressure increased 26.82 13.69 47 48619 101881 42470788
Ear haemorrhage 26.05 13.69 16 48650 1078 42571591
Abdominal pain 25.63 13.69 121 48545 190350 42382319
Cataract 25.53 13.69 85 48581 30519 42542150
Muscle spasms 25.51 13.69 177 48489 85867 42486802
Myositis 25.48 13.69 54 48612 14812 42557857
Iodine uptake abnormal 25.42 13.69 5 48661 5 42572664
Infective exacerbation of chronic obstructive airways disease 25.40 13.69 20 48646 2013 42570656
Confusional state 25.27 13.69 102 48564 167495 42405174
Haemorrhagic disorder 25.26 13.69 14 48652 778 42571891
Tremor 25.22 13.69 45 48621 96884 42475785
Stomatitis 25.13 13.69 119 48547 50210 42522459
Flushing 24.58 13.69 6 48660 37022 42535647
B-cell small lymphocytic lymphoma 24.52 13.69 9 48657 186 42572483
Lymph node haemorrhage 24.46 13.69 6 48660 27 42572642
Lymphoedema 24.09 13.69 29 48637 4919 42567750
Splenic haemorrhage 23.93 13.69 12 48654 543 42572126
Infection 23.57 13.69 213 48453 111855 42460814
Cardiac disorder 23.21 13.69 114 48552 48818 42523851
Pyrexia 23.16 13.69 601 48065 393441 42179228
Psychotic disorder 23.13 13.69 3 48663 29205 42543464
Loss of consciousness 23.03 13.69 44 48622 92310 42480359
Mucormycosis 22.70 13.69 34 48632 7109 42565560
Chronic graft versus host disease in skin 22.69 13.69 17 48649 1589 42571080
Hyperhidrosis 22.68 13.69 43 48623 90469 42482200
Bacterial pericarditis 22.65 13.69 7 48659 83 42572586
Purpura 22.54 13.69 45 48621 11834 42560835
Eosinophilia 22.49 13.69 5 48661 32894 42539775
Urticaria 22.47 13.69 31 48635 74005 42498664
Hypersensitivity 22.27 13.69 30 48636 72340 42500329
Lymphoma 22.25 13.69 50 48616 14271 42558398
Skin lesion 22.24 13.69 75 48591 27099 42545570
Vitreous haemorrhage 22.07 13.69 21 48645 2726 42569943
International normalised ratio increased 21.86 13.69 14 48652 48154 42524515
Acute kidney injury 21.85 13.69 292 48374 367045 42205624
Pain 21.77 13.69 177 48489 244671 42327998
Pyoderma gangrenosum 21.71 13.69 18 48648 1949 42570720
Erysipelas 21.50 13.69 31 48635 6265 42566404
Respiratory failure 21.34 13.69 232 48434 127900 42444769
Giardiasis 21.29 13.69 11 48655 530 42572139
Aggression 21.21 13.69 12 48654 44151 42528518
Paraesthesia 21.07 13.69 32 48634 73427 42499242
Lung operation 21.03 13.69 7 48659 107 42572562
Eye operation 20.77 13.69 11 48655 558 42572111
Deep vein thrombosis 20.68 13.69 35 48631 76922 42495747
Decreased immune responsiveness 20.57 13.69 18 48648 2097 42570572
Blood urea increased 20.47 13.69 6 48660 32787 42539882
Sleep disorder 20.47 13.69 15 48651 48080 42524589
Bladder operation 20.26 13.69 8 48658 203 42572466
Bradycardia 20.22 13.69 42 48624 85442 42487227
Skin haemorrhage 20.19 13.69 34 48632 7851 42564818
Renal impairment 20.00 13.69 62 48604 110166 42462503
Lymphopenia 19.89 13.69 62 48604 21501 42551168
Eye haemorrhage 19.84 13.69 26 48640 4804 42567865
Biopsy 19.65 13.69 9 48657 332 42572337
Product dose omission issue 19.64 13.69 100 48566 154265 42418404
Meningitis enteroviral 19.33 13.69 5 48661 29 42572640
Pulmonary mass 19.10 13.69 51 48615 16214 42556455
Supportive care 19.07 13.69 4 48662 7 42572662
C-reactive protein increased 18.90 13.69 27 48639 63533 42509136
Nightmare 18.81 13.69 3 48663 25009 42547660
Weight increased 18.71 13.69 62 48604 107921 42464748
Lymphoma transformation 18.62 13.69 10 48656 522 42572147
Blood pressure fluctuation 18.58 13.69 4 48662 26904 42545765
Obstructive airways disorder 18.55 13.69 3 48663 24756 42547913
Blood glucose increased 18.47 13.69 35 48631 73664 42499005
Blood cholesterol increased 18.41 13.69 4 48662 26737 42545932
Angioedema 18.40 13.69 13 48653 42464 42530205
Fungal abscess central nervous system 18.33 13.69 7 48659 162 42572507
Hyperuricaemia 18.24 13.69 36 48630 9388 42563281
Hypomagnesaemia 18.17 13.69 5 48661 28483 42544186
Lymphocyte count abnormal 18.11 13.69 17 48649 2170 42570499
Immunodeficiency 18.09 13.69 31 48635 7259 42565410
Diffuse large B-cell lymphoma recurrent 18.08 13.69 25 48641 4861 42567808
Supraventricular tachycardia 17.82 13.69 42 48624 12366 42560303
Hepatitis B reactivation 17.81 13.69 24 48642 4554 42568115
Chronic graft versus host disease in eye 17.81 13.69 8 48658 282 42572387
Gastric haemorrhage 17.80 13.69 38 48628 10477 42562192
Coma 17.72 13.69 21 48645 53533 42519136
Conjunctival haemorrhage 17.68 13.69 21 48645 3512 42569157
Transurethral prostatectomy 17.67 13.69 9 48657 421 42572248
Immunodeficiency common variable 17.65 13.69 8 48658 288 42572381
Cardiomyopathy 17.51 13.69 55 48611 19155 42553514
Heart rate decreased 17.44 13.69 10 48656 36522 42536147
Medication error 17.43 13.69 8 48658 33146 42539523
Anaphylactic reaction 17.34 13.69 14 48652 42729 42529940
Restlessness 17.11 13.69 6 48660 29243 42543426
Reticulocyte count increased 17.08 13.69 11 48655 806 42571863
Speech disorder 16.99 13.69 6 48660 29115 42543554
Human herpesvirus 6 infection reactivation 16.97 13.69 9 48657 458 42572211
Contraindicated product administered 16.96 13.69 4 48662 25268 42547401
Therapeutic product effect decreased 16.93 13.69 12 48654 39138 42533531
Cardiac fibrillation 16.89 13.69 10 48656 630 42572039
B-cell small lymphocytic lymphoma recurrent 16.89 13.69 4 48662 15 42572654
Skin mass 16.87 13.69 24 48642 4792 42567877
Dyspnoea 16.62 13.69 382 48284 442239 42130430
Muscle haemorrhage 16.62 13.69 22 48644 4103 42568566
Central nervous system haemorrhage 16.58 13.69 6 48660 119 42572550
Neck mass 16.52 13.69 15 48651 1835 42570834
Mantle cell lymphoma stage IV 16.44 13.69 5 48661 56 42572613
Sepsis 16.38 13.69 319 48347 199015 42373654
Abnormal behaviour 16.22 13.69 5 48661 26446 42546223
Pneumonitis 16.21 13.69 92 48574 41626 42531043
Chronic hepatitis B 16.17 13.69 6 48660 128 42572541
Discouragement 16.09 13.69 9 48657 509 42572160
Procedural haemorrhage 16.09 13.69 18 48648 2823 42569846
Wrong technique in product usage process 16.04 13.69 15 48651 42620 42530049
Skin infection 15.99 13.69 34 48632 9346 42563323
Central nervous system lymphoma 15.97 13.69 13 48653 1372 42571297
Cytopenia 15.86 13.69 50 48616 17447 42555222
Cerebral fungal infection 15.85 13.69 8 48658 367 42572302
Gait disturbance 15.81 13.69 58 48608 97942 42474727
Hyphaema 15.81 13.69 10 48656 710 42571959
Palliative care 15.64 13.69 12 48654 1162 42571507
Granuloma skin 15.64 13.69 12 48654 1163 42571506
Blood lactate dehydrogenase increased 15.53 13.69 65 48601 26016 42546653
Arteriosclerotic retinopathy 15.49 13.69 4 48662 23 42572646
Altered state of consciousness 15.48 13.69 7 48659 29252 42543417
Intensive care 15.46 13.69 12 48654 1182 42571487
Pneumonia fungal 15.42 13.69 33 48633 9113 42563556
Gamma-glutamyltransferase increased 15.37 13.69 9 48657 32488 42540181
Scrotal haematocoele 15.35 13.69 4 48662 24 42572645
Papilloma excision 15.25 13.69 3 48663 3 42572666
Hepatic steatosis 15.20 13.69 3 48663 21445 42551224
Pneumocystis jirovecii pneumonia 15.18 13.69 63 48603 25118 42547551
Soft tissue infection 15.15 13.69 17 48649 2676 42569993
Leukostasis syndrome 15.03 13.69 6 48660 157 42572512
Aspartate aminotransferase increased 15.01 13.69 42 48624 77121 42495548
Pneumonia cryptococcal 15.00 13.69 13 48653 1495 42571174
Medical procedure 14.78 13.69 6 48660 164 42572505
Hallucination, visual 14.77 13.69 3 48663 21017 42551652
Malaise 14.73 13.69 163 48503 211993 42360676
Cardiac failure congestive 14.71 13.69 156 48510 85446 42487223
Lactic acidosis 14.71 13.69 18 48648 45243 42527426
Graft versus host disease 14.65 13.69 40 48626 12885 42559784
Abdominal discomfort 14.61 13.69 41 48625 75214 42497455
Paronychia 14.60 13.69 21 48645 4234 42568435
Alanine aminotransferase increased 14.48 13.69 52 48614 88354 42484315
Transient aphasia 14.47 13.69 9 48657 620 42572049
Irritability 14.46 13.69 7 48659 28121 42544548
Central nervous system fungal infection 14.43 13.69 8 48658 445 42572224
Dental operation 14.41 13.69 8 48658 446 42572223
Human rhinovirus test positive 14.35 13.69 7 48659 298 42572371
Oxygen saturation decreased 14.29 13.69 33 48633 64654 42508015
Seizure 14.27 13.69 80 48586 120481 42452188
Iridocyclitis 14.26 13.69 15 48651 2196 42570473
Ureteric compression 14.22 13.69 7 48659 304 42572365
Product use complaint 14.14 13.69 15 48651 2216 42570453
Calculus bladder 14.02 13.69 12 48654 1358 42571311
Malignant pleural effusion 13.94 13.69 14 48652 1941 42570728
Lethargy 13.86 13.69 20 48646 46870 42525799
Central nervous system infection 13.84 13.69 10 48656 884 42571785
Synovial cyst 13.78 13.69 16 48650 2613 42570056
Application site laceration 13.73 13.69 3 48663 7 42572662
Orthostatic hypotension 13.71 13.69 9 48657 30561 42542108
Inguinal hernia 13.71 13.69 31 48635 8881 42563788

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 1453.55 13.80 1132 61622 228510 110298035
Death 939.95 13.80 1528 61226 697341 109829204
Incorrect dose administered 542.15 13.80 458 62296 103183 110423362
Disease progression 520.71 13.80 666 62088 243368 110283177
Off label use 450.11 13.80 1856 60898 1498329 109028216
Lymphocytosis 397.99 13.80 140 62614 5271 110521274
Lymphadenopathy 335.49 13.80 283 62471 63552 110462993
Platelet count decreased 333.97 13.80 523 62231 229920 110296625
Pleural effusion 302.62 13.80 435 62319 177274 110349271
Lymphocyte count increased 283 13.80 118 62636 7085 110519460
White blood cell count increased 274.89 13.80 306 62448 96536 110430009
Pneumonia 245.71 13.80 1065 61689 875649 109650896
Haematoma 242.99 13.80 227 62527 58249 110468296
Petechiae 234.91 13.80 153 62601 23164 110503381
Tumour lysis syndrome 229.85 13.80 168 62586 30633 110495912
Pericardial effusion 224.17 13.80 215 62539 57002 110469543
Bronchopulmonary aspergillosis 214.09 13.80 159 62595 29704 110496841
Subdural haematoma 213.17 13.80 172 62582 36282 110490263
Cerebral aspergillosis 210.04 13.80 70 62684 2232 110524313
Haemorrhage 188.60 13.80 266 62488 106426 110420119
Mantle cell lymphoma recurrent 168.81 13.80 49 62705 977 110525568
Aspergillus infection 167.27 13.80 129 62625 25487 110501058
Epistaxis 167.00 13.80 280 62474 130092 110396453
Thrombocytopenia 156.39 13.80 494 62260 348391 110178154
Hypogammaglobulinaemia 155.46 13.80 112 62642 19964 110506581
Drug hypersensitivity 155.21 13.80 34 62720 454056 110072489
Neutropenia 149.59 13.80 510 62244 374110 110152435
Rheumatoid arthritis 147.60 13.80 5 62749 299608 110226937
Chronic lymphocytic leukaemia recurrent 145.94 13.80 44 62710 1005 110525540
Cytokine release syndrome 143.51 13.80 188 62566 70118 110456427
Contusion 143.05 13.80 370 62384 232991 110293554
Condition aggravated 137.30 13.80 129 62625 734707 109791838
Ecchymosis 137.17 13.80 98 62656 17240 110509305
Chronic lymphocytic leukaemia 136.41 13.80 67 62687 5901 110520644
Cerebral haemorrhage 134.58 13.80 175 62579 64793 110461752
Atrial flutter 134.52 13.80 111 62643 24151 110502394
Febrile neutropenia 128.83 13.80 434 62320 316333 110210212
Splenomegaly 125.34 13.80 107 62647 24391 110502154
COVID-19 120.93 13.80 359 62395 244701 110281844
Arthropathy 120.02 13.80 12 62742 287510 110239035
Completed suicide 119.53 13.80 4 62750 242377 110284168
Leukocytosis 119.38 13.80 150 62604 53678 110472867
Haemoglobin decreased 118.61 13.80 360 62394 248367 110278178
Cardiac failure 115.48 13.80 298 62456 187328 110339217
Increased tendency to bruise 110.76 13.80 74 62680 11684 110514861
Haematuria 108.56 13.80 180 62574 82825 110443720
Autoimmune haemolytic anaemia 108.04 13.80 70 62684 10497 110516048
Neutrophil count decreased 107.44 13.80 222 62532 120719 110405826
Pain 107.16 13.80 240 62514 954715 109571830
Haemothorax 106.65 13.80 60 62694 6971 110519574
Glossodynia 104.96 13.80 5 62749 221999 110304546
Contraindicated product administered 104.56 13.80 10 62744 248257 110278288
Microsporidia infection 101.13 13.80 36 62718 1403 110525142
Therapeutic product effect decreased 99.89 13.80 11 62743 244305 110282240
Hepatic enzyme increased 98.18 13.80 30 62724 320862 110205683
Sepsis 97.61 13.80 406 62348 326940 110199605
Diffuse large B-cell lymphoma 97.16 13.80 77 62677 15821 110510724
Infusion related reaction 96.26 13.80 48 62706 381114 110145431
Toxicity to various agents 96.12 13.80 79 62675 480476 110046069
Haemorrhage intracranial 95.25 13.80 99 62655 28870 110497675
Wheezing 93.72 13.80 16 62738 255214 110271331
Diffuse large B-cell lymphoma recurrent 93.51 13.80 53 62701 6246 110520299
Musculoskeletal stiffness 93.45 13.80 22 62732 279800 110246745
Onychoclasis 91.84 13.80 55 62699 7182 110519363
Hypersensitivity 87.72 13.80 61 62693 403937 110122608
Drug intolerance 87.44 13.80 62 62692 406450 110120095
Joint swelling 87.08 13.80 74 62680 442771 110083774
COVID-19 pneumonia 86.35 13.80 106 62648 37037 110489508
Abdominal discomfort 86.13 13.80 59 62695 393799 110132746
Cytopenia 85.10 13.80 95 62659 30021 110496524
Basal cell carcinoma 84.63 13.80 116 62638 45154 110481391
Mobility decreased 82.65 13.80 17 62737 237405 110289140
Injection site pain 81.01 13.80 5 62749 177917 110348628
Asthma 81.00 13.80 21 62733 250270 110276275
Campylobacter infection 80.29 13.80 35 62719 2344 110524201
Helicobacter infection 80.21 13.80 6 62748 181871 110344674
Discomfort 79.84 13.80 13 62741 214694 110311851
Urticaria 79.23 13.80 41 62713 318816 110207729
Blood cholesterol increased 78.99 13.80 7 62747 184778 110341767
Vasogenic cerebral oedema 78.76 13.80 34 62720 2224 110524321
Wound 77.16 13.80 19 62735 234418 110292127
Drug ineffective 76.42 13.80 528 62226 1520012 109006533
Chronic lymphocytic leukaemia transformation 75.97 13.80 20 62734 273 110526272
Mantle cell lymphoma 74.22 13.80 30 62724 1662 110524883
Alopecia 74.11 13.80 59 62695 364694 110161851
Irritable bowel syndrome 73.62 13.80 5 62749 164210 110362335
Respiratory failure 70.45 13.80 275 62479 215057 110311488
Swelling 69.79 13.80 58 62696 350983 110175562
Pericardial haemorrhage 69.73 13.80 41 62713 5176 110521369
Pyrexia 69.64 13.80 797 61957 897468 109629077
Overdose 69.46 13.80 23 62731 233771 110292774
Nausea 66.57 13.80 420 62334 1235270 109291275
Post procedural haemorrhage 63.98 13.80 60 62694 15452 110511093
Arrhythmia 63.28 13.80 129 62625 69446 110457099
Sleep disorder 59.96 13.80 19 62735 198625 110327920
Cystoid macular oedema 59.74 13.80 30 62724 2770 110523775
Paraesthesia 59.66 13.80 42 62712 276479 110250066
Ill-defined disorder 59.43 13.80 9 62745 156844 110369701
Haematotympanum 59.15 13.80 11 62743 22 110526523
Blood blister 58.72 13.80 33 62721 3826 110522719
Mantle cell lymphoma refractory 58.29 13.80 14 62740 128 110526417
Polymyositis 57.21 13.80 32 62722 3676 110522869
Cardiac tamponade 57.05 13.80 49 62705 11258 110515287
Weight increased 56.92 13.80 94 62660 419550 110106995
Intentional overdose 56.67 13.80 5 62749 132496 110394049
Subdural haemorrhage 56.36 13.80 39 62715 6519 110520026
Pseudomonas infection 56.07 13.80 74 62680 27779 110498766
Purpura 55.72 13.80 69 62685 24319 110502226
White blood cell count abnormal 54.53 13.80 39 62715 6870 110519675
Migraine 54.40 13.80 15 62739 171637 110354908
Hepatitis E 54.29 13.80 33 62721 4426 110522119
Injury 53.42 13.80 17 62737 177248 110349297
Lymphocyte count decreased 53.08 13.80 107 62647 57136 110469409
Splenic rupture 52.61 13.80 27 62727 2610 110523935
Pruritus 52.26 13.80 163 62591 581397 109945148
Chronic graft versus host disease 51.86 13.80 43 62711 9414 110517131
Squamous cell carcinoma 51.75 13.80 58 62696 18405 110508140
Loss of personal independence in daily activities 51.66 13.80 11 62743 150009 110376536
Septic shock 51.36 13.80 201 62553 157327 110369218
Malaise 51.19 13.80 202 62552 671617 109854928
Folliculitis 50.66 13.80 16 62738 167637 110358908
Hyperuricaemia 50.19 13.80 51 62703 14480 110512065
Haemorrhage subcutaneous 50.11 13.80 34 62720 5505 110521040
Therapy partial responder 49.29 13.80 81 62673 36980 110489565
Psoriasis 48.75 13.80 10 62744 139983 110386562
Brain abscess 48.39 13.80 36 62718 6738 110519807
Lymphoma 47.59 13.80 58 62696 20113 110506432
Skin toxicity 47.50 13.80 45 62709 11738 110514807
Haemolytic anaemia 47.49 13.80 59 62695 20861 110505684
Intentional product misuse 47.32 13.80 9 62745 132895 110393650
Haemorrhagic diathesis 47.25 13.80 37 62717 7471 110519074
Blister 47.14 13.80 36 62718 227340 110299205
Type 2 diabetes mellitus 46.73 13.80 21 62733 177211 110349334
Joint range of motion decreased 46.13 13.80 7 62747 121825 110404720
Anxiety 46.13 13.80 78 62676 345000 110181545
Uveitis 45.75 13.80 59 62695 21651 110504894
Ear haemorrhage 45.75 13.80 24 62730 2427 110524118
Diarrhoea 45.72 13.80 903 61851 1138602 109387943
Vomiting 45.66 13.80 316 62438 910359 109616186
Progressive multifocal leukoencephalopathy 45.22 13.80 63 62691 24893 110501652
Sudden death 44.82 13.80 62 62692 24333 110502212
Inguinal hernia 44.20 13.80 36 62718 7689 110518856
Blood urine present 43.62 13.80 61 62693 24184 110502361
Anaemia 42.52 13.80 486 62268 546600 109979945
Pneumonitis 42.43 13.80 117 62637 76414 110450131
Platelet count abnormal 41.80 13.80 32 62722 6250 110520295
Erysipelas 41.52 13.80 44 62710 13114 110513431
Blood lactate dehydrogenase increased 41.26 13.80 83 62671 44251 110482294
Malignant syphilis 41.23 13.80 9 62745 51 110526494
Prostatic operation 40.81 13.80 13 62741 358 110526187
Bursitis 39.97 13.80 12 62742 129906 110396639
Obesity 39.67 13.80 8 62746 113343 110413202
Capillary permeability increased 39.60 13.80 9 62745 63 110526482
Nasopharyngitis 39.44 13.80 105 62649 394256 110132289
Urinary tract infection 39.29 13.80 318 62436 325964 110200581
Injection site erythema 39.09 13.80 4 62750 94172 110432373
Pneumonia fungal 39.06 13.80 45 62709 14709 110511836
Confusional state 38.88 13.80 136 62618 468544 110058001
Cardiac failure congestive 38.63 13.80 179 62575 150821 110375724
C-reactive protein increased 38.57 13.80 40 62714 217879 110308666
Impaired healing 38.46 13.80 33 62721 196684 110329861
Eye haemorrhage 38.27 13.80 40 62714 11734 110514811
Pancytopenia 37.46 13.80 225 62529 209388 110317157
Cytomegalovirus infection reactivation 37.35 13.80 49 62705 18284 110508261
Hypercholesterolaemia 37.34 13.80 4 62750 90833 110435712
Lip dry 37.33 13.80 6 62748 100077 110426468
Gastrointestinal disorder 36.85 13.80 50 62704 241902 110284643
Suicide attempt 36.81 13.80 7 62747 103387 110423158
Peripheral venous disease 36.45 13.80 3 62751 84114 110442431
Immune effector cell-associated neurotoxicity syndrome 35.68 13.80 43 62711 14739 110511806
Flushing 35.41 13.80 8 62746 104728 110421817
Osteoarthritis 35.26 13.80 31 62723 182592 110343953
Pneumocystis jirovecii pneumonia 35.09 13.80 76 62678 42659 110483886
Gastric haemorrhage 34.72 13.80 44 62710 15871 110510674
Surgery 34.56 13.80 74 62680 41209 110485336
Mucormycosis 34.36 13.80 36 62718 10592 110515953
Vitreous haemorrhage 34.00 13.80 25 62729 4595 110521950
Cryptococcosis 33.95 13.80 25 62729 4606 110521939
Neurological symptom 33.81 13.80 43 62711 15565 110510980
White blood cell count decreased 33.49 13.80 234 62520 229156 110297389
Chronic graft versus host disease in skin 33.48 13.80 20 62734 2599 110523946
Leukostasis syndrome 33.18 13.80 10 62744 228 110526317
Bone marrow transplant 33.13 13.80 17 62737 1643 110524902
Product quality issue 32.83 13.80 3 62751 77296 110449249
Stem cell transplant 32.68 13.80 24 62730 4403 110522142
Iridocyclitis 32.63 13.80 26 62728 5382 110521163
Pyoderma gangrenosum 32.34 13.80 26 62728 5450 110521095
Infective exacerbation of chronic obstructive airways disease 32.29 13.80 21 62733 3169 110523376
Agitation 32.06 13.80 12 62742 113039 110413506
Medication error 31.93 13.80 10 62744 105356 110421189
Skin lesion 31.71 13.80 82 62672 51549 110474996
Syncope 31.59 13.80 210 62544 202326 110324219
Abdominal lymphadenopathy 31.58 13.80 17 62737 1811 110524734
Blood pressure fluctuation 31.52 13.80 3 62751 74821 110451724
Discouragement 31.30 13.80 18 62736 2180 110524365
Abdominal pain upper 31.21 13.80 98 62656 349013 110177532
Scleroderma 31.02 13.80 27 62727 6314 110520231
Suicidal ideation 30.15 13.80 8 62746 93929 110432616
Cataract 29.71 13.80 106 62648 79379 110447166
Cardiac disorder 29.61 13.80 103 62651 76177 110450368
Fungal abscess central nervous system 29.35 13.80 9 62745 218 110526327
Lower limb fracture 29.29 13.80 4 62750 75344 110451201
Hepatitis B reactivation 29.06 13.80 28 62726 7456 110519089
Encephalitis 28.95 13.80 44 62710 18795 110507750
Iodine uptake abnormal 28.91 13.80 5 62749 5 110526540
Liver injury 28.47 13.80 26 62728 150387 110376158
Abdominal pain 28.19 13.80 173 62581 512816 110013729
Haemophagocytic lymphohistiocytosis 28.08 13.80 58 62696 31501 110495044
Giardiasis 27.64 13.80 11 62743 585 110525960
Electrocardiogram QT prolonged 27.05 13.80 14 62740 108946 110417599
Depressed level of consciousness 27.04 13.80 15 62739 112263 110414282
Lymphopenia 26.98 13.80 66 62688 40104 110486441
Supraventricular tachycardia 26.75 13.80 49 62705 24373 110502172
Autoimmune disorder 26.62 13.80 3 62751 65480 110461065
Haemoptysis 26.53 13.80 95 62659 71259 110455286
Anaphylactic reaction 26.48 13.80 16 62738 114284 110412261
Cellulitis 26.28 13.80 141 62613 125875 110400670
Muscle spasms 26.20 13.80 257 62497 277900 110248645
Gingival bleeding 25.89 13.80 43 62711 19796 110506749
Insomnia 25.80 13.80 111 62643 360479 110166066
Liver function test increased 25.78 13.80 9 62745 88539 110438006
Bacterial pericarditis 25.73 13.80 7 62747 109 110526436
Cardiomyopathy 25.69 13.80 58 62696 33467 110493078
Blood pressure increased 25.66 13.80 69 62685 258304 110268241
Underdose 25.61 13.80 3 62751 63551 110462994
Stress 25.47 13.80 14 62740 105334 110421211
Hospitalisation 25.47 13.80 153 62601 142340 110384205
Biopsy 25.31 13.80 11 62743 731 110525814
Depression 25.03 13.80 94 62660 317241 110209304
Gait disturbance 24.93 13.80 78 62676 278130 110248415
Hospice care 24.89 13.80 33 62721 12440 110514105
Subarachnoid haemorrhage 24.59 13.80 53 62701 29649 110496896
B-cell small lymphocytic lymphoma recurrent 24.54 13.80 5 62749 19 110526526
Spinal fracture 24.28 13.80 45 62709 22588 110503957
Splenic haemorrhage 24.26 13.80 11 62743 809 110525736
Headache 24.14 13.80 354 62400 882023 109644522
Hyphaema 24.03 13.80 12 62742 1095 110525450
Sinusitis 23.97 13.80 87 62667 296601 110229944
Acute myeloid leukaemia 23.90 13.80 61 62693 38049 110488496
Anal squamous cell carcinoma 23.86 13.80 11 62743 841 110525704
Chronic graft versus host disease in eye 23.82 13.80 9 62745 416 110526129
Mass 23.57 13.80 41 62713 19589 110506956
Road traffic accident 23.56 13.80 16 62738 107382 110419163
Somnolence 23.53 13.80 88 62666 297361 110229184
Muscle haemorrhage 23.52 13.80 24 62730 6845 110519700
Transurethral prostatectomy 23.35 13.80 8 62746 278 110526267
Hypoglycaemia 23.28 13.80 19 62735 116085 110410460
Malignant pleural effusion 23.26 13.80 19 62735 4074 110522471
Myalgia 23.20 13.80 210 62544 222171 110304374
Wound infection 23.06 13.80 13 62741 96452 110430093
Lymph node haemorrhage 22.66 13.80 5 62749 30 110526515
Hypercalcaemia 22.63 13.80 68 62686 46589 110479956
Transplant 22.44 13.80 12 62742 1262 110525283
Herpes zoster 22.42 13.80 121 62633 108258 110418287
Conjunctival haemorrhage 22.40 13.80 23 62731 6610 110519935
Colitis ulcerative 22.29 13.80 8 62746 77355 110449190
Infectious pleural effusion 22.28 13.80 20 62734 4871 110521674
Lymphocyte count abnormal 22.20 13.80 15 62739 2411 110524134
Squamous cell carcinoma of skin 22.07 13.80 37 62717 17166 110509379
Hyperphosphataemia 22.05 13.80 36 62718 16345 110510200
Myositis 21.83 13.80 52 62702 31064 110495481
B-cell small lymphocytic lymphoma 21.73 13.80 7 62747 200 110526345
Hypoaesthesia 21.70 13.80 98 62656 314125 110212420
Blood pressure decreased 21.66 13.80 20 62734 115071 110411474
Pneumonia pseudomonal 21.65 13.80 24 62730 7522 110519023
Pulmonary mass 21.64 13.80 58 62696 37243 110489302
Product use issue 21.58 13.80 271 62483 311424 110215121
Haematotoxicity 21.47 13.80 41 62713 21041 110505504
Ejection fraction decreased 21.19 13.80 61 62693 40819 110485726
Angioedema 21.18 13.80 15 62739 98485 110428060
Haemorrhagic disorder 21.01 13.80 13 62741 1800 110524745
Gastrointestinal haemorrhage 20.82 13.80 163 62591 165355 110361190
Meningitis cryptococcal 20.76 13.80 19 62735 4743 110521802
Lymphoma transformation 20.76 13.80 9 62745 595 110525950
Erythema 20.67 13.80 90 62664 291357 110235188
Prostatitis 20.63 13.80 19 62735 4782 110521763
Therapeutic product effect incomplete 20.58 13.80 62 62692 223743 110302802
Oxygen saturation decreased 20.49 13.80 36 62718 156946 110369599
Chronic lymphocytic leukaemia refractory 20.47 13.80 6 62748 124 110526421
Gout 20.36 13.80 56 62698 36510 110490035
Lymphoedema 20.35 13.80 33 62721 14896 110511649
Prostate cancer 20.32 13.80 57 62697 37584 110488961
Retinal haemorrhage 20.30 13.80 26 62728 9475 110517070
Abdominal mass 20.16 13.80 19 62735 4922 110521623
Oedema 20.15 13.80 57 62697 209919 110316626
Supportive care 20.12 13.80 4 62750 13 110526532
Paronychia 20.11 13.80 28 62726 11053 110515492
Skin cancer 19.88 13.80 36 62718 17748 110508797
Bacteraemia 19.83 13.80 61 62693 42329 110484216
Graft versus host disease 19.68 13.80 37 62717 18769 110507776
Haemorrhage urinary tract 19.63 13.80 15 62739 2921 110523624
Central nervous system haemorrhage 19.63 13.80 8 62746 453 110526092
Mantle cell lymphoma stage IV 19.58 13.80 5 62749 60 110526485
Incorrect route of product administration 19.55 13.80 6 62748 64055 110462490
Transient aphasia 19.37 13.80 9 62745 700 110525845
Coma 19.35 13.80 23 62731 117846 110408699
Subcutaneous haematoma 19.19 13.80 15 62739 3021 110523524
Metabolic acidosis 19.17 13.80 17 62737 99727 110426818
Skin haemorrhage 19.08 13.80 43 62711 24784 110501761
Ureteric compression 18.88 13.80 7 62747 307 110526238
Blood creatine phosphokinase increased 18.73 13.80 9 62745 73068 110453477
Blood pressure systolic increased 18.70 13.80 12 62742 82979 110443566
Eye operation 18.66 13.80 14 62740 2653 110523892
Procedural haemorrhage 18.66 13.80 19 62735 5408 110521137
Memory impairment 18.51 13.80 54 62700 196890 110329655
Hypertensive crisis 18.49 13.80 42 62712 24330 110502215
Eosinophilia 18.47 13.80 5 62749 57931 110468614
Product use complaint 18.21 13.80 16 62738 3787 110522758
Pneumonia pneumococcal 18.20 13.80 18 62736 4947 110521598
Blood disorder 18.12 13.80 25 62729 9785 110516760
Hepatic steatosis 18.05 13.80 3 62751 48828 110477717
Lymph node palpable 17.95 13.80 6 62748 193 110526352
Hip fracture 17.78 13.80 52 62702 35099 110491446
Soft tissue infection 17.77 13.80 18 62736 5089 110521456
Lung operation 17.70 13.80 7 62747 366 110526179
International normalised ratio increased 17.64 13.80 14 62740 86758 110439787
Myelodysplastic syndrome 17.59 13.80 54 62700 37430 110489115
Laboratory test abnormal 17.52 13.80 60 62694 44019 110482526
Hallucination 17.51 13.80 19 62735 101413 110425132
Angina bullosa haemorrhagica 17.39 13.80 6 62748 213 110526332
Non-cardiac chest pain 17.37 13.80 25 62729 10173 110516372
Meningitis enteroviral 17.35 13.80 5 62749 97 110526448
Central nervous system fungal infection 17.33 13.80 8 62746 613 110525932
Reticulocyte count increased 17.31 13.80 11 62743 1595 110524950
Mouth haemorrhage 17.29 13.80 29 62725 13459 110513086
Lower respiratory tract infection 17.28 13.80 75 62679 243031 110283514
Neoplasm 17.19 13.80 26 62728 11061 110515484
Injection site bruising 17.16 13.80 4 62750 51259 110475286
Gait inability 17.15 13.80 32 62722 136344 110390201
Blood immunoglobulin M increased 17.12 13.80 11 62743 1626 110524919
Central nervous system lymphoma 17.02 13.80 14 62740 3030 110523515
Depressed mood 16.98 13.80 74 62680 60735 110465810
Immunodeficiency common variable 16.94 13.80 8 62746 646 110525899
Pain in extremity 16.80 13.80 186 62568 486932 110039613
Panniculitis 16.74 13.80 31 62723 15551 110510994
Obstructive airways disorder 16.69 13.80 3 62751 46146 110480399
Fungal infection 16.68 13.80 65 62689 50741 110475804
Lymphadenitis 16.68 13.80 18 62736 5475 110521070
Haemolysis 16.65 13.80 31 62723 15608 110510937
Wrong technique in product usage process 16.65 13.80 15 62739 87333 110439212
Haemoglobin abnormal 16.65 13.80 23 62731 9015 110517530
Sinus node dysfunction 16.63 13.80 23 62731 9024 110517521
Arteriosclerotic retinopathy 16.52 13.80 4 62750 38 110526507
Papilloma excision 16.49 13.80 3 62751 5 110526540
Onychomadesis 16.45 13.80 3 62751 45660 110480885
Pneumonia bacterial 16.43 13.80 42 62712 26219 110500326
Beta 2 microglobulin increased 16.41 13.80 8 62746 693 110525852
Calculus bladder 16.37 13.80 11 62743 1753 110524792
Gastritis 16.27 13.80 67 62687 53632 110472913
Uveal melanoma 16.15 13.80 4 62750 42 110526503
SARS-CoV-2 test positive 16.11 13.80 32 62722 16903 110509642
Heart rate decreased 16.03 13.80 14 62740 82742 110443803
Product use in unapproved indication 16.01 13.80 349 62405 447028 110079517
Trichophytosis 15.94 13.80 7 62747 477 110526068
Herpes virus infection 15.94 13.80 22 62732 8616 110517929
Restlessness 15.90 13.80 6 62748 56253 110470292
Feeling hot 15.80 13.80 17 62737 91089 110435456
Gastrooesophageal reflux disease 15.73 13.80 51 62703 179925 110346620
Agranulocytosis 15.63 13.80 73 62681 61687 110464858
Lymph node pain 15.62 13.80 11 62743 1891 110524654
Pulmonary oedema 15.46 13.80 104 62650 100555 110425990
Human herpesvirus 6 infection reactivation 15.42 13.80 9 62745 1120 110525425
Osteoporosis 15.41 13.80 16 62738 87136 110439409
Taste disorder 15.36 13.80 9 62745 65378 110461167
Ventricular fibrillation 15.35 13.80 55 62699 41258 110485287
Underweight 15.31 13.80 10 62744 1520 110525025
Back injury 15.28 13.80 4 62750 47395 110479150
Pseudohyperkalaemia 15.27 13.80 3 62751 9 110526536
Tremor 15.23 13.80 61 62693 202171 110324374
Skin mass 15.19 13.80 23 62731 9793 110516752
Peptic ulcer haemorrhage 15.11 13.80 9 62745 1164 110525381
Scrotal haematocoele 15.03 13.80 3 62751 10 110526535
Hyperviscosity syndrome 14.91 13.80 7 62747 558 110525987
Chronic hepatitis B 14.88 13.80 7 62747 560 110525985
Pneumonia cryptococcal 14.87 13.80 12 62742 2530 110524015
Prostatomegaly 14.85 13.80 15 62739 4227 110522318
Dyspnoea 14.65 13.80 498 62256 1106374 109420171
Diabetic ketoacidosis 14.65 13.80 3 62751 42055 110484490
Swollen tongue 14.62 13.80 8 62746 60354 110466191
Musculoskeletal pain 14.56 13.80 54 62700 182969 110343576
Tyrosine kinase mutation 14.55 13.80 4 62750 65 110526480
Neck pain 14.52 13.80 30 62724 123100 110403445
Chemotherapy 14.43 13.80 11 62743 2135 110524410
Pallor 14.40 13.80 7 62747 56460 110470085
Graft versus host disease in lung 14.39 13.80 9 62745 1269 110525276
Non-small cell lung cancer 14.33 13.80 20 62734 7915 110518630
Morphoea 14.31 13.80 7 62747 611 110525934
Transient ischaemic attack 14.31 13.80 73 62681 63909 110462636
Nervous system disorder 14.24 13.80 45 62709 31676 110494869
Tooth extraction 14.15 13.80 26 62728 12965 110513580
Post herpetic neuralgia 14.06 13.80 13 62741 3288 110523257
Breast haematoma 14.02 13.80 5 62749 196 110526349
Cystitis haemorrhagic 14.01 13.80 25 62729 12184 110514361
Full blood count abnormal 13.99 13.80 66 62688 55986 110470559
Enterovirus infection 13.97 13.80 12 62742 2758 110523787
Frequent bowel movements 13.92 13.80 12 62742 71378 110455167
Heart rate increased 13.83 13.80 39 62715 143795 110382750
Malignant melanoma 13.82 13.80 30 62724 16861 110509684

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
MeSH PA D000092004 Tyrosine Kinase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76617 EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor

Related Drugs by ATC class:

L01EL Bruton's tyrosine kinase (BTK) inhibitors 4 drugs
acalabrutinibpirtobrutinibtirabrutinib hydrochloridezanubrutinib

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 8476284 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8476284 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8476284 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS 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 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8497277 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
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
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8703780 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8703780 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8952015 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8952015 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8952015 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8952015 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8952015 Dec. 28, 2026 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
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
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8563563 April 26, 2027 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8563563 April 26, 2027 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8563563 April 26, 2027 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8563563 April 26, 2027 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8563563 April 26, 2027 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
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 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 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
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 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 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
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 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 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
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 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 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
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 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 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
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 10004746 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10004746 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10004746 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10004746 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10016435 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS 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 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10478439 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
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
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10751342 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10751342 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10751342 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10751342 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 11672803 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 11672803 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 11672803 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 11672803 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8999999 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8999999 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8999999 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 8999999 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9125889 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801881 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801881 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801883 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801883 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801883 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
70MG/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 9801883 June 3, 2031 TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
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 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 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 10463668 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/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION ORAL 10695350 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/ML IMBRUVICA PHARMACYCLICS LLC N217003 Aug. 24, 2022 RX SUSPENSION 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/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 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
Potassium voltage-gated channel subfamily H member 2 Ion channel Ki 5.96 CHEMBL
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
Tyrosine-protein kinase Fgr Kinase INHIBITOR IC50 8.48 SCIENTIFIC LITERATURE
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
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
Tyrosine-protein kinase FRK Kinase Kd 6.23 CHEMBL
Redox-regulatory protein FAM213A Enzyme IC50 6.05 CHEMBL
Platelet glycoprotein VI Membrane receptor 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 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
Dual specificity mitogen-activated protein kinase kinase 5 Kinase Kd 6.61 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
DB09053 DRUGBANK_ID
1X70OSD4VX UNII
1442981 RXNORM
207254 MMSL
29840 MMSL
d08170 MMSL
015287 NDDF
710228002 SNOMEDCT_US
715598009 SNOMEDCT_US
C3501358 UMLSCUI
9566 INN_ID
24821094 PUBCHEM_CID
1X70OSD4VX INXIGHT DRUGS

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 57962-014 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 57962-140 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 57962-420 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