buprenorphine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 434 52485-79-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • buprenorphine
  • buprenorfine
  • norspan
  • buprenorphine hydrochloride
  • buprenorphine HCl
A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
  • Molecular weight: 467.65
  • Formula: C29H41NO4
  • CLOGP: 3.99
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 62.16
  • ALOGS: -4.44
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.20 mg P
1.20 mg SL
1.20 mg TD
1.60 mg implant
2.10 mg P
8 mg SL
8 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 17 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.04 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 28 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 19, 2019 EMA L. Molteni & C. dei Fratelli Alitti Societร  di Esercizio S.p.A.
Dec. 29, 1981 FDA RECKITT BENCKISER

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
Application site pruritus 1723.75 12.70 407 34522 3577 63450516
Product adhesion issue 1716.21 12.70 419 34510 4300 63449793
Drug withdrawal syndrome 1527.96 12.70 571 34358 26623 63427470
Application site erythema 1212.11 12.70 319 34610 4516 63449577
Application site rash 944.63 12.70 229 34700 2269 63451824
Inadequate analgesia 707.98 12.70 188 34741 2755 63451338
Application site pain 704.83 12.70 202 34727 3980 63450113
Application site vesicles 701.65 12.70 162 34767 1273 63452820
Application site burn 559.81 12.70 122 34807 712 63453381
Drug abuse 543.10 12.70 391 34538 72127 63381966
Drug withdrawal syndrome neonatal 515.13 12.70 136 34793 1945 63452148
Drug dependence 403.00 12.70 218 34711 24265 63429828
Application site irritation 374.73 12.70 102 34827 1648 63452445
Maternal exposure during pregnancy 367.14 12.70 524 34405 219538 63234555
Foetal exposure during pregnancy 256.64 12.70 180 34749 31782 63422311
Wrong technique in product usage process 246.37 12.70 232 34697 62108 63391985
Exposure during pregnancy 243.87 12.70 360 34569 155187 63298906
Application site scar 236.17 12.70 48 34881 187 63453906
Substance abuse 233.75 12.70 91 34838 4716 63449377
Application site discharge 225.11 12.70 44 34885 133 63453960
Application site erosion 208.87 12.70 42 34887 153 63453940
Application site exfoliation 183.82 12.70 44 34885 410 63453683
Application site dryness 183.74 12.70 37 34892 136 63453957
Application site discolouration 167.16 12.70 46 34883 775 63453318
Blepharospasm 159.55 12.70 74 34855 5922 63448171
Withdrawal syndrome 156.72 12.70 111 34818 19886 63434207
Premature delivery 145.77 12.70 126 34803 30155 63423938
Application site urticaria 140.92 12.70 32 34897 231 63453862
Product solubility abnormal 125.21 12.70 37 34892 813 63453280
Abortion spontaneous 123.73 12.70 141 34788 47054 63407039
Toxicity to various agents 123.22 12.70 356 34573 246894 63207199
Taste disorder 119.16 12.70 81 34848 13581 63440512
Product physical issue 115.76 12.70 56 34873 4924 63449169
Overdose 113.96 12.70 217 34712 114861 63339232
Application site reaction 112.03 12.70 33 34896 717 63453376
Application site swelling 111.30 12.70 31 34898 547 63453546
Somnolence 110.81 12.70 279 34650 178406 63275687
Product packaging quantity issue 108.13 12.70 37 34892 1322 63452771
Product administered at inappropriate site 106.60 12.70 46 34883 3103 63450990
Epilepsy 99.77 12.70 97 34832 26968 63427125
Placental disorder 96.91 12.70 35 34894 1469 63452624
Respiratory depression 95.77 12.70 71 34858 13644 63440449
Hyperaesthesia 95.00 12.70 61 34868 9297 63444796
Placental hypertrophy 91.09 12.70 14 34915 0 63454093
Hyperhidrosis 88.40 12.70 188 34741 107648 63346445
Yawning 88.26 12.70 30 34899 1050 63453043
Drug screen positive 84.93 12.70 41 34888 3588 63450505
Therapeutic product effect increased 84.80 12.70 30 34899 1185 63452908
Drug delivery system removal 84.58 12.70 13 34916 0 63454093
Jaundice neonatal 80.75 12.70 27 34902 898 63453195
Inappropriate schedule of product administration 80.35 12.70 177 34752 103788 63350305
Drug detoxification 78.83 12.70 21 34908 311 63453782
Intentional product misuse 78.52 12.70 129 34800 60788 63393305
Arthropathy 77.88 12.70 17 34912 234775 63219318
Euphoric mood 76.15 12.70 42 34887 4845 63449248
Pemphigus 75.52 12.70 7 34922 183719 63270374
Synovitis 74.53 12.70 8 34921 186910 63267183
Maternal exposure during breast feeding 73.19 12.70 39 34890 4202 63449891
Injection site pain 72.52 12.70 195 34734 129605 63324488
Oral administration complication 72.32 12.70 16 34913 101 63453992
Treatment failure 71.11 12.70 12 34917 199031 63255062
Accidental exposure to product by child 70.32 12.70 26 34903 1167 63452926
Application site dermatitis 70.02 12.70 17 34912 169 63453924
Systemic lupus erythematosus 69.54 12.70 15 34914 208903 63245190
Abortion induced 69.23 12.70 52 34877 10190 63443903
Application site ulcer 68.45 12.70 15 34914 90 63454003
Drug screen negative 66.86 12.70 18 34911 278 63453815
Exposure via breast milk 66.21 12.70 29 34900 2028 63452065
Sinusitis 64.68 12.70 22 34907 226631 63227462
Application site scab 64.11 12.70 16 34913 180 63453913
Foetal growth restriction 64.01 12.70 44 34885 7509 63446584
Rhesus incompatibility 63.61 12.70 14 34915 86 63454007
Product physical consistency issue 63.39 12.70 21 34908 678 63453415
Infusion related reaction 63.18 12.70 28 34901 245493 63208600
Breakthrough pain 62.03 12.70 24 34905 1222 63452871
Alopecia 61.62 12.70 57 34872 337479 63116614
Hand deformity 60.66 12.70 8 34921 159449 63294644
Contraindicated product administered 60.60 12.70 22 34907 217626 63236467
Injection site extravasation 60.00 12.70 45 34884 8796 63445297
Drug use disorder 59.45 12.70 36 34893 4948 63449145
Accidental overdose 58.31 12.70 68 34861 23241 63430852
Joint swelling 56.71 12.70 58 34871 327608 63126485
Selective abortion 56.30 12.70 14 34915 155 63453938
Stress cardiomyopathy 55.19 12.70 44 34885 9406 63444687
Injection site infection 54.88 12.70 25 34904 1918 63452175
Fatigue 52.76 12.70 281 34648 887747 62566346
Application site haemorrhage 50.15 12.70 20 34909 1104 63452989
Hallucination 50.10 12.70 100 34829 54717 63399376
Swelling 49.65 12.70 47 34882 275331 63178762
Disturbance in attention 49.37 12.70 81 34848 38108 63415985
Pyrexia 49.23 12.70 117 34812 470361 62983732
Pericarditis 49.10 12.70 7 34922 131572 63322521
Hepatic enzyme increased 46.17 12.70 27 34902 202301 63251792
Defaecation disorder 45.96 12.70 17 34912 764 63453329
Device leakage 45.69 12.70 35 34894 7061 63447032
Diarrhoea 44.88 12.70 222 34707 715144 62738949
Injection site cellulitis 44.69 12.70 19 34910 1235 63452858
Miosis 44.58 12.70 35 34894 7318 63446775
Skin irritation 43.78 12.70 39 34890 9702 63444391
Suicidal ideation 43.45 12.70 102 34827 62319 63391774
Infection 42.62 12.70 38 34891 229135 63224958
Subchondral insufficiency fracture 41.81 12.70 9 34920 49 63454044
Nasopharyngitis 41.75 12.70 47 34882 254210 63199883
Dermatitis contact 41.59 12.70 40 34889 10968 63443125
Prescription drug used without a prescription 41.34 12.70 22 34907 2364 63451729
Poor feeding infant 41.24 12.70 13 34916 357 63453736
Product dispensing issue 41.10 12.70 11 34918 166 63453927
Alcohol abuse 40.63 12.70 21 34908 2125 63451968
Intentional underdose 40.26 12.70 20 34909 1862 63452231
Echocardiogram abnormal 39.53 12.70 18 34911 1380 63452713
Rheumatoid arthritis 39.44 12.70 49 34880 253770 63200323
Anti-cyclic citrullinated peptide antibody positive 39.35 12.70 8 34921 116204 63337889
Drug diversion 39.30 12.70 16 34913 932 63453161
Bradycardia foetal 39.15 12.70 13 34916 423 63453670
17 ketosteroids urine abnormal 39.04 12.70 6 34923 0 63454093
Application site odour 38.80 12.70 8 34921 34 63454059
Congenital coronary artery malformation 38.19 12.70 10 34919 138 63453955
Impaired reasoning 37.98 12.70 9 34920 80 63454013
Arthralgia 37.90 12.70 173 34756 569537 62884556
Glossodynia 37.88 12.70 26 34903 178850 63275243
Migraine 36.97 12.70 133 34796 103213 63350880
Vomiting 36.66 12.70 469 34460 559148 62894945
Abdominal discomfort 36.63 12.70 76 34853 320809 63133284
Respiratory arrest 36.60 12.70 65 34864 32580 63421513
Application site inflammation 36.54 12.70 12 34917 377 63453716
Musculoskeletal stiffness 36.30 12.70 29 34900 184589 63269504
Cough 35.42 12.70 67 34862 292676 63161417
Rheumatoid factor positive 35.25 12.70 3 34926 84403 63369690
Low birth weight baby 34.97 12.70 30 34899 7099 63446994
Application site induration 34.88 12.70 6 34923 6 63454087
Febrile neutropenia 34.64 12.70 11 34918 118438 63335655
Therapy naive 33.72 12.70 7 34922 31 63454062
Gastrointestinal disorder 33.68 12.70 15 34914 131224 63322869
White blood cell count decreased 32.53 12.70 18 34911 139086 63315007
Haemoglobin decreased 32.36 12.70 20 34909 145465 63308628
Helicobacter infection 32.23 12.70 6 34923 92779 63361314
Platelet count decreased 31.86 12.70 12 34917 116110 63337983
Duodenal ulcer perforation 31.70 12.70 5 34924 87204 63366889
Unresponsive to stimuli 31.26 12.70 62 34867 33754 63420339
Drug interaction 30.40 12.70 223 34706 228908 63225185
Hypersensitivity 30.39 12.70 73 34856 292612 63161481
Application site bruise 30.27 12.70 10 34919 320 63453773
Neutropenia 30.21 12.70 31 34898 174974 63279119
Premature baby 29.57 12.70 46 34883 20689 63433404
Injection site abscess 29.45 12.70 14 34915 1184 63452909
Application site papules 28.71 12.70 7 34922 71 63454022
Neurosis 28.15 12.70 9 34920 259 63453834
Injection site ulcer 27.94 12.70 11 34918 587 63453506
Thrombocytopenia 26.98 12.70 26 34903 151131 63302962
Product colour issue 26.93 12.70 11 34918 646 63453447
Memory impairment 26.74 12.70 121 34808 104137 63349956
Sinus arrhythmia 26.70 12.70 14 34915 1459 63452634
Foetal malformation 26.17 12.70 8 34921 198 63453895
Faeces soft 26.00 12.70 23 34906 5669 63448424
Eyelid retraction 25.88 12.70 6 34923 48 63454045
Hypertension 25.68 12.70 74 34855 279229 63174864
Monoplegia 25.61 12.70 18 34911 3183 63450910
Maternal drugs affecting foetus 25.59 12.70 22 34907 5220 63448873
Small for dates baby 25.25 12.70 19 34910 3732 63450361
Endocarditis staphylococcal 24.80 12.70 9 34920 383 63453710
Faecaloma 24.75 12.70 26 34903 7915 63446178
Genitourinary symptom 24.50 12.70 6 34923 62 63454031
Application site perspiration 24.30 12.70 5 34924 21 63454072
Tooth hypoplasia 24.25 12.70 6 34923 65 63454028
Injection site oedema 24.24 12.70 13 34916 1419 63452674
Conjunctival haemorrhage 23.77 12.70 18 34911 3569 63450524
Hepatitis C 23.47 12.70 21 34908 5253 63448840
Delirium 23.39 12.70 71 34858 50470 63403623
Condition aggravated 23.34 12.70 128 34801 402089 63052004
Victim of sexual abuse 23.18 12.70 10 34919 674 63453419
Vulvar basal cell carcinoma 22.82 12.70 5 34924 30 63454063
Asphyxia 22.48 12.70 22 34907 6159 63447934
Maternal use of illicit drugs 22.36 12.70 4 34925 6 63454087
Product contamination 22.17 12.70 10 34919 750 63453343
Dermatitis allergic 22.15 12.70 34 34895 15114 63438979
Pneumonia 22.02 12.70 154 34775 456613 62997480
Irritable bowel syndrome 21.81 12.70 9 34920 82403 63371690
Pre-eclampsia 21.77 12.70 26 34903 9107 63444986
Gastrooesophageal reflux disease 21.61 12.70 107 34822 95532 63358561
Folliculitis 21.52 12.70 6 34923 70311 63383782
Judgement impaired 21.30 12.70 10 34919 822 63453271
Focal segmental glomerulosclerosis 21.19 12.70 12 34917 1456 63452637
Psoriatic arthropathy 21.16 12.70 12 34917 91508 63362585
Somnolence neonatal 21.12 12.70 6 34923 114 63453979
Muscle injury 21.10 12.70 5 34924 65340 63388753
Stillbirth 20.86 12.70 22 34907 6728 63447365
Urinary incontinence 20.85 12.70 51 34878 31963 63422130
Product substitution issue 20.76 12.70 34 34895 15962 63438131
Therapeutic response shortened 20.74 12.70 29 34900 11859 63442234
Accidental poisoning 20.69 12.70 9 34920 619 63453474
Agitation 20.59 12.70 76 34853 59681 63394412
Cerebral vasoconstriction 20.54 12.70 11 34918 1197 63452896
Premature rupture of membranes 20.50 12.70 19 34910 4974 63449119
Extra dose administered 20.16 12.70 21 34908 6329 63447764
Application site infection 19.97 12.70 5 34924 57 63454036
Ill-defined disorder 19.96 12.70 10 34919 81745 63372348
Tremor neonatal 19.88 12.70 6 34923 142 63453951
Disease progression 19.79 12.70 23 34906 122735 63331358
Depressed level of consciousness 19.78 12.70 77 34852 62001 63392092
Pupil constriction procedure 19.52 12.70 3 34926 0 63454093
Blood cholesterol increased 19.45 12.70 14 34915 94018 63360075
Injection site necrosis 19.44 12.70 11 34918 1333 63452760
Pancreatic steatosis 19.40 12.70 10 34919 1006 63453087
Constipation 19.36 12.70 199 34730 224744 63229349
Neonatal aspiration 19.24 12.70 6 34923 159 63453934
Radial nerve palsy 19.18 12.70 8 34921 496 63453597
Impaired healing 19.05 12.70 17 34912 102525 63351568
Therapy non-responder 18.96 12.70 9 34920 75892 63378201
Gastrointestinal hypomotility 18.82 12.70 10 34919 1071 63453022
Product dose omission issue 18.78 12.70 66 34863 234247 63219846
Heart rate abnormal 18.73 12.70 18 34911 4929 63449164
Weight increased 18.62 12.70 77 34852 260715 63193378
Expulsion of medication 18.55 12.70 4 34925 22 63454071
Sedation 18.41 12.70 55 34874 38754 63415339
Enlarged uvula 18.41 12.70 6 34923 184 63453909
Injection site erosion 18.35 12.70 5 34924 81 63454012
Product prescribing error 18.33 12.70 43 34886 26246 63427847
Pancytopenia 18.09 12.70 16 34913 96917 63357176
Dyspnoea 18.01 12.70 256 34673 661057 62793036
Foetal death 18.00 12.70 26 34903 10954 63443139
Substance dependence 17.99 12.70 6 34923 198 63453895
Application site pustules 17.98 12.70 4 34925 26 63454067
Influenza 17.93 12.70 20 34909 108702 63345391
Interstitial lung disease 17.65 12.70 6 34923 61902 63392191
Bruxism 17.63 12.70 15 34914 3510 63450583
Neonatal respiratory distress 17.52 12.70 7 34922 388 63453705
Respiratory acidosis 17.48 12.70 20 34909 6695 63447398
Application site discomfort 17.47 12.70 7 34922 391 63453702
Abdominal pain upper 17.46 12.70 182 34747 206262 63247831
Product quality issue 17.18 12.70 51 34878 35814 63418279
Product odour abnormal 17.12 12.70 10 34919 1286 63452807
Neutrophil count decreased 16.91 12.70 5 34924 56401 63397692
Type 2 diabetes mellitus 16.86 12.70 7 34922 63861 63390232
Premature labour 16.80 12.70 27 34902 12477 63441616
Nausea 16.74 12.70 600 34329 853871 62600222
Bronchitis 16.53 12.70 27 34902 124908 63329185
Cardio-respiratory arrest 16.43 12.70 71 34858 59888 63394205
Persistent depressive disorder 16.29 12.70 9 34920 1041 63453052
Dental discomfort 16.14 12.70 7 34922 478 63453615
Arterial thrombosis 16.13 12.70 10 34919 1433 63452660
Wound 15.93 12.70 42 34887 163221 63290872
Off label use 15.69 12.70 269 34660 674193 62779900
Pharyngitis streptococcal 15.67 12.70 24 34905 10648 63443445
Mental disorder 15.53 12.70 40 34889 25879 63428214
Psoriasis 15.46 12.70 15 34914 86942 63367151
Hypersomnia 15.38 12.70 32 34897 18023 63436070
Application site laceration 15.36 12.70 3 34926 9 63454084
Dyspnoea exertional 15.29 12.70 7 34922 60295 63393798
Feeling of body temperature change 15.20 12.70 16 34913 4881 63449212
Lack of application site rotation 15.12 12.70 3 34926 10 63454083
Anaemia 15.08 12.70 97 34832 293333 63160760
Repetitive strain injury 14.96 12.70 5 34924 166 63453927
Oral mucosal blistering 14.79 12.70 17 34912 5716 63448377
Adjacent segment degeneration 14.70 12.70 3 34926 12 63454081
Product size issue 14.66 12.70 6 34923 354 63453739
Confusional state 14.51 12.70 196 34733 236184 63217909
Product monitoring error 14.46 12.70 15 34914 4501 63449592
Mobility decreased 14.39 12.70 28 34901 121131 63332962
Application site warmth 14.37 12.70 5 34924 188 63453905
Application site paraesthesia 14.34 12.70 4 34925 71 63454022
Lymphocytosis 14.30 12.70 12 34917 2755 63451338
Rash 14.25 12.70 220 34709 560651 62893442
Tooth discolouration 14.21 12.70 8 34921 960 63453133
Labelled drug-drug interaction medication error 14.15 12.70 26 34903 13373 63440720
Glomerular filtration rate 13.99 12.70 3 34926 16 63454077
Ankyloglossia congenital 13.98 12.70 5 34924 204 63453889
Therapeutic response increased 13.94 12.70 6 34923 402 63453691
Serotonin syndrome 13.94 12.70 41 34888 28641 63425452
Cataract 13.89 12.70 7 34922 57046 63397047
Coma 13.82 12.70 71 34858 64293 63389800
Premature separation of placenta 13.82 12.70 10 34919 1851 63452242
Psychomotor skills impaired 13.77 12.70 11 34918 2357 63451736
Drug abuser 13.73 12.70 12 34917 2911 63451182
Femoral neck fracture 13.70 12.70 20 34909 8503 63445590
Cystic lymphangioma 13.69 12.70 3 34926 18 63454075
Viral titre decreased 13.69 12.70 3 34926 18 63454075
Productive cough 13.62 12.70 9 34920 63199 63390894
Bradypnoea 13.60 12.70 13 34916 3537 63450556
COVID-19 13.55 12.70 26 34903 113077 63341016
Reaction to excipient 13.53 12.70 9 34920 1455 63452638
Learning disability 13.47 12.70 5 34924 227 63453866
Restlessness 13.27 12.70 41 34888 29412 63424681
Application site hypersensitivity 13.24 12.70 5 34924 238 63453855
Lack of administration site rotation 13.17 12.70 3 34926 22 63454071
Substance abuser 13.17 12.70 3 34926 22 63454071
Paraesthesia 13.09 12.70 138 34791 156828 63297265
Hip arthroplasty 12.94 12.70 5 34924 47641 63406452
Lip swelling 12.87 12.70 42 34887 31021 63423072
Gastric cyst 12.86 12.70 4 34925 105 63453988
Lividity 12.73 12.70 5 34924 265 63453828
Injection site inflammation 12.73 12.70 13 34916 3830 63450263
Kleptomania 12.73 12.70 3 34926 26 63454067
Drug dependence, antepartum 12.73 12.70 3 34926 26 63454067

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
Drug abuse 1799.74 14.74 1133 31969 97963 34825866
Drug withdrawal syndrome 1757.28 14.74 672 32430 19162 34904667
Drug dependence 1120.36 14.74 517 32585 23700 34900129
Intentional product misuse 788.14 14.74 507 32595 45104 34878725
Substance abuse 636.65 14.74 248 32854 7393 34916436
Product adhesion issue 582.79 14.74 159 32943 1441 34922388
Toxicity to various agents 573.08 14.74 818 32284 199544 34724285
Miosis 560.37 14.74 241 32861 9294 34914535
Drug withdrawal syndrome neonatal 548.85 14.74 183 32919 3436 34920393
Injection site pain 450.83 14.74 339 32763 38666 34885163
Application site pruritus 374.71 14.74 110 32992 1327 34922502
Withdrawal syndrome 295.77 14.74 170 32932 12285 34911544
Inadequate analgesia 292.45 14.74 109 32993 2866 34920963
Application site erythema 279.67 14.74 99 33003 2237 34921592
Application site rash 279.01 14.74 78 33024 779 34923050
Drug use disorder 262.90 14.74 111 32991 4080 34919749
Intentional product use issue 262.69 14.74 303 32799 59513 34864316
Overdose 260.77 14.74 373 32729 90686 34833143
Alcohol abuse 241.26 14.74 108 32994 4582 34919247
Coma 230.74 14.74 249 32853 45429 34878400
Foetal exposure during pregnancy 221.62 14.74 224 32878 37877 34885952
Application site burn 206.25 14.74 47 33055 181 34923648
Respiratory depression 202.71 14.74 148 32954 16097 34907732
Myelopathy 200.66 14.74 79 33023 2418 34921411
Injection site infection 184.30 14.74 59 33043 967 34922862
Somnolence 184.10 14.74 356 32746 110760 34813069
Asphyxia 177.63 14.74 99 33003 6736 34917093
Injection site abscess 174.04 14.74 54 33048 795 34923034
Drug screen positive 168.99 14.74 80 33022 3863 34919966
Injection site ulcer 168.68 14.74 41 33061 221 34923608
Application site vesicles 159.46 14.74 47 33055 575 34923254
Drug detoxification 156.64 14.74 39 33063 236 34923593
Drug delivery system removal 149.09 14.74 25 33077 0 34923829
Application site pain 148.53 14.74 59 33043 1849 34921980
Injection site erythema 144.31 14.74 120 32982 15779 34908050
Wrong technique in product usage process 142.44 14.74 173 32929 35813 34888016
Accidental overdose 133.04 14.74 127 32975 20013 34903816
Drug screen negative 130.49 14.74 31 33071 149 34923680
Brain oedema 124.78 14.74 104 32998 13717 34910112
Injection site necrosis 111.64 14.74 33 33069 408 34923421
Accidental poisoning 108.11 14.74 37 33065 753 34923076
Maternal exposure during breast feeding 107.36 14.74 44 33058 1497 34922332
Agitation 106.21 14.74 193 32909 57206 34866623
Injection site erosion 101.25 14.74 23 33079 87 34923742
Application site irritation 100.80 14.74 34 33068 661 34923168
Febrile neutropenia 99.53 14.74 8 33094 136841 34786988
Compartment syndrome 98.86 14.74 51 33051 2967 34920862
Injection site extravasation 97.19 14.74 50 33052 2892 34920937
Euphoric mood 92.94 14.74 61 33041 5580 34918249
Quadriparesis 86.69 14.74 38 33064 1531 34922298
Jaundice neonatal 85.57 14.74 36 33066 1310 34922519
Aggression 79.77 14.74 137 32965 38827 34885002
Diarrhoea 79.51 14.74 156 32946 389756 34534073
Pyrexia 77.10 14.74 123 32979 332890 34590939
Application site reaction 74.53 14.74 24 33078 401 34923428
Bradypnoea 73.56 14.74 41 33061 2788 34921041
Poor feeding infant 72.90 14.74 25 33077 512 34923317
Exposure via breast milk 71.76 14.74 36 33066 1974 34921855
Brachial artery entrapment syndrome 71.56 14.74 12 33090 0 34923829
Drug diversion 71.28 14.74 28 33074 851 34922978
Atrial fibrillation 70.38 14.74 15 33087 122378 34801451
Accidental exposure to product by child 69.60 14.74 32 33070 1444 34922385
Logorrhoea 68.15 14.74 37 33065 2389 34921440
Pulmonary oedema 66.31 14.74 142 32960 47387 34876442
Intentional removal of drug delivery system by patient 65.60 14.74 11 33091 0 34923829
Visceral congestion 65.28 14.74 24 33078 606 34923223
Hyperhidrosis 65.17 14.74 188 32914 75504 34848325
Inappropriate schedule of product administration 64.91 14.74 166 32936 62130 34861699
Drug interaction 64.76 14.74 400 32702 225546 34698283
Depressed level of consciousness 64.43 14.74 132 32970 42709 34881120
Cough 64.15 14.74 31 33071 150109 34773720
Pneumonia 63.26 14.74 158 32944 362469 34561360
Platelet count decreased 62.38 14.74 18 33084 119699 34804130
Injection site vesicles 61.49 14.74 24 33078 717 34923112
Dysarthria 60.58 14.74 114 32988 34668 34889161
Poisoning 60.50 14.74 66 33036 12160 34911669
Cluster headache 60.27 14.74 22 33080 544 34923285
Spinal shock 60.05 14.74 13 33089 37 34923792
Application site dryness 57.51 14.74 14 33088 76 34923753
Injection site discharge 57.30 14.74 17 33085 213 34923616
Congenital multiplex arthrogryposis 56.45 14.74 13 33089 53 34923776
Injection site cellulitis 56.04 14.74 21 33081 560 34923269
Death 55.68 14.74 598 32504 397451 34526378
Application site urticaria 54.29 14.74 13 33089 65 34923764
Prescription drug used without a prescription 52.70 14.74 30 33072 2124 34921705
Premature baby 52.50 14.74 78 33024 19555 34904274
Deafness neurosensory 52.11 14.74 33 33069 2838 34920991
Tremor neonatal 51.80 14.74 18 33084 384 34923445
White blood cell count decreased 50.36 14.74 14 33088 95431 34828398
Hepatitis C 50.27 14.74 54 33048 9776 34914053
Neutropenia 49.91 14.74 45 33057 156733 34767096
Rhabdomyolysis 49.02 14.74 159 32943 68004 34855825
Dermo-hypodermitis 48.97 14.74 18 33084 454 34923375
Drug abuser 46.99 14.74 35 33067 3919 34919910
Low birth weight baby 46.86 14.74 47 33055 7858 34915971
Disease progression 46.62 14.74 22 33080 108055 34815774
Cardiac failure congestive 46.26 14.74 11 33091 83259 34840570
Injection site warmth 45.88 14.74 27 33075 2035 34921794
Application site swelling 45.80 14.74 15 33087 265 34923564
Therapeutic product effect increased 45.09 14.74 19 33083 694 34923135
Impaired driving ability 44.66 14.74 29 33073 2604 34921225
Dyspnoea 44.38 14.74 195 32907 376587 34547242
Product solubility abnormal 43.74 14.74 17 33085 502 34923327
Product dose omission issue 43.58 14.74 30 33072 119681 34804148
Haemoglobin decreased 43.00 14.74 31 33071 120741 34803088
Sarcopenia 42.65 14.74 16 33086 428 34923401
Endocarditis staphylococcal 42.58 14.74 16 33086 430 34923399
Hallucination 42.46 14.74 126 32976 51372 34872457
COVID-19 41.61 14.74 11 33091 77539 34846290
Disorientation 41.58 14.74 95 33007 33093 34890736
Product dispensing issue 41.12 14.74 10 33092 54 34923775
Arthralgia 40.96 14.74 61 33041 169980 34753849
Neuropathy peripheral 40.71 14.74 14 33088 83249 34840580
Application site discolouration 40.67 14.74 14 33088 290 34923539
Oral administration complication 40.52 14.74 10 33092 58 34923771
Substance use disorder 40.25 14.74 18 33084 761 34923068
Breech presentation 40.18 14.74 12 33090 154 34923675
Application site exfoliation 40.18 14.74 12 33090 154 34923675
Injection site irritation 40.07 14.74 21 33081 1262 34922567
Restlessness 40.06 14.74 80 33022 25402 34898427
Fatigue 39.99 14.74 198 32904 370455 34553374
Intentional underdose 39.59 14.74 17 33085 651 34923178
Product administered at inappropriate site 38.84 14.74 25 33077 2211 34921618
Asthenia 38.78 14.74 112 32990 245139 34678690
Skin irritation 38.39 14.74 36 33066 5541 34918288
Application site hypersensitivity 38.30 14.74 11 33091 122 34923707
Application site scar 37.99 14.74 8 33094 19 34923810
Foetal distress syndrome 37.22 14.74 19 33083 1081 34922748
Aptyalism 36.92 14.74 14 33088 386 34923443
Hypotension 36.68 14.74 99 33003 221550 34702279
Application site discharge 36.36 14.74 11 33091 148 34923681
Housebound 35.93 14.74 12 33090 226 34923603
Application site erosion 35.75 14.74 10 33092 100 34923729
Substance use 35.74 14.74 16 33086 678 34923151
Anxiety 35.60 14.74 187 32915 99241 34824588
Injection site swelling 35.52 14.74 49 33053 11478 34912351
Endocarditis 35.48 14.74 37 33065 6474 34917355
Decreased gait velocity 35.32 14.74 11 33091 164 34923665
Acute kidney injury 35.16 14.74 159 32943 304829 34619000
Congestive hepatopathy 35.09 14.74 22 33080 1859 34921970
Injection site pruritus 35.08 14.74 38 33064 6945 34916884
Prescription form tampering 34.84 14.74 14 33088 452 34923377
Therapeutic product effect decreased 34.53 14.74 91 33011 34652 34889177
Product packaging quantity issue 34.23 14.74 17 33085 912 34922917
Infusion related reaction 33.74 14.74 5 33097 53052 34870777
Interstitial lung disease 33.64 14.74 10 33092 65272 34858557
Incorrect route of product administration 32.76 14.74 54 33048 14791 34909038
Anaemia 32.36 14.74 113 32989 233222 34690607
Phlebotomy 32.17 14.74 9 33093 90 34923739
Malignant neoplasm progression 32.12 14.74 22 33080 88024 34835805
Off label use 31.81 14.74 250 32852 419274 34504555
Pleural effusion 31.63 14.74 19 33083 81527 34842302
Respiratory arrest 31.57 14.74 77 33025 27966 34895863
Wrong dose 31.46 14.74 14 33088 585 34923244
Bradyphrenia 31.18 14.74 30 33072 4768 34919061
Hyponatraemia 31.06 14.74 20 33082 82671 34841158
Persecutory delusion 31.02 14.74 23 33079 2557 34921272
Thrombocytopenia 30.43 14.74 64 33038 156183 34767646
Road traffic accident 30.13 14.74 57 33045 17393 34906436
Epistaxis 29.88 14.74 9 33093 58242 34865587
Suicidal ideation 29.73 14.74 95 33007 40293 34883536
Sedation 29.55 14.74 63 33039 20943 34902886
Rash 29.47 14.74 110 32992 222642 34701187
Glomerulonephritis acute 28.66 14.74 9 33093 138 34923691
Cerebrovascular accident 28.60 14.74 23 33079 84788 34839041
Injection site inflammation 28.59 14.74 15 33087 903 34922926
Vestibular ischaemia 28.57 14.74 6 33096 14 34923815
Blood creatinine increased 28.17 14.74 29 33073 94947 34828882
Blood glucose increased 28.12 14.74 14 33088 66704 34857125
Feeding intolerance 28.02 14.74 9 33093 149 34923680
Aspartate aminotransferase increased 27.42 14.74 15 33087 67768 34856061
Thrombosis 27.36 14.74 7 33095 50451 34873378
Substance dependence 26.90 14.74 11 33091 372 34923457
Ear deformity acquired 26.36 14.74 5 33097 5 34923824
Haemorrhage 26.23 14.74 8 33094 51362 34872467
Agitation neonatal 26.10 14.74 15 33087 1081 34922748
Injection site bruising 25.46 14.74 36 33066 8627 34915202
Application site scab 25.21 14.74 7 33095 68 34923761
Dehydration 24.66 14.74 54 33048 129915 34793914
Treatment failure 24.34 14.74 7 33095 46690 34877139
Product use issue 24.07 14.74 121 32981 63095 34860734
Respiratory rate decreased 23.91 14.74 19 33083 2340 34921489
Coronary artery disease 23.82 14.74 8 33094 48297 34875532
Altered state of consciousness 23.81 14.74 61 33041 22832 34900997
Mastication disorder 23.39 14.74 15 33087 1318 34922511
Vestibular disorder 23.34 14.74 14 33088 1093 34922736
Myocardial infarction 23.23 14.74 50 33052 121035 34802794
Hyperkalaemia 23.17 14.74 19 33083 69370 34854459
Joint swelling 23.16 14.74 14 33088 59876 34863953
Rhesus incompatibility 23.10 14.74 6 33096 44 34923785
Dependence 22.85 14.74 14 33088 1136 34922693
Back pain 22.78 14.74 51 33051 121738 34802091
Prostate cancer 22.48 14.74 5 33097 39644 34884185
Herpes zoster 22.43 14.74 3 33099 34396 34889433
Expulsion of medication 22.32 14.74 6 33096 51 34923778
Clumsiness 22.09 14.74 16 33086 1716 34922113
Pneumonia aspiration 21.81 14.74 88 33014 41815 34882014
Electrocardiogram T wave alternans 21.79 14.74 5 33097 20 34923809
Application site haemorrhage 21.61 14.74 10 33092 458 34923371
Paranoia 21.55 14.74 40 33062 12028 34911801
Hypoventilation 21.53 14.74 21 33081 3393 34920436
International normalised ratio increased 21.39 14.74 9 33093 47318 34876511
Hallucination, visual 21.26 14.74 50 33052 17741 34906088
Joint hyperextension 21.10 14.74 7 33095 129 34923700
Diabetes mellitus 21.04 14.74 9 33093 46864 34876965
Delirium 21.02 14.74 90 33012 43901 34879928
Chronic actinic dermatitis 20.88 14.74 5 33097 25 34923804
Behavioural addiction 20.77 14.74 6 33096 68 34923761
Product physical issue 20.63 14.74 18 33084 2523 34921306
Neonatal aspiration 20.38 14.74 6 33096 73 34923756
Weight increased 19.92 14.74 36 33066 92997 34830832
Hypoxic-ischaemic encephalopathy 19.91 14.74 23 33079 4509 34919320
Coordination abnormal 19.90 14.74 30 33072 7614 34916215
Troponin T increased 19.66 14.74 17 33085 2354 34921475
Blood bilirubin increased 19.48 14.74 6 33096 38290 34885539
Pancytopenia 19.34 14.74 38 33064 95119 34828710
Poisoning deliberate 19.32 14.74 30 33072 7814 34916015
Accidental death 19.15 14.74 17 33085 2439 34921390
Intentional overdose 19.09 14.74 87 33015 43587 34880242
Pulmonary congestion 19.03 14.74 41 33061 13724 34910105
Bronchitis 18.93 14.74 8 33094 41955 34881874
Renal failure 18.90 14.74 62 33040 130495 34793334
Adrenergic syndrome 18.87 14.74 6 33096 96 34923733
Injection site induration 18.81 14.74 18 33084 2842 34920987
Therapy naive 18.76 14.74 5 33097 41 34923788
Micrognathia 18.64 14.74 8 33094 306 34923523
Alcohol interaction 18.53 14.74 18 33084 2895 34920934
Abdominal distension 18.33 14.74 17 33085 58475 34865354
Neutrophil count decreased 18.32 14.74 13 33089 51091 34872738
Product use in unapproved indication 18.28 14.74 54 33048 117445 34806384
Laryngomalacia 18.21 14.74 8 33094 324 34923505
Psoriasis 18.16 14.74 7 33095 38805 34885024
Application site odour 17.89 14.74 3 33099 0 34923829
Injection site ischaemia 17.89 14.74 3 33099 0 34923829
Infection 17.88 14.74 37 33065 90878 34832951
Sepsis 17.87 14.74 89 33013 166472 34757357
Intentional misuse of drug delivery system 17.85 14.74 4 33098 14 34923815
Unresponsive to stimuli 17.75 14.74 62 33040 27507 34896322
Hypertonia 17.74 14.74 21 33081 4225 34919604
Hypertension 17.61 14.74 68 33034 136375 34787454
Dementia with Lewy bodies 17.60 14.74 10 33092 705 34923124
Respiratory failure 17.54 14.74 49 33053 108523 34815306
Product contamination 17.51 14.74 10 33092 712 34923117
Brief psychotic disorder with marked stressors 17.48 14.74 7 33095 224 34923605
Product substitution issue 17.45 14.74 33 33069 10062 34913767
Gastrointestinal haemorrhage 17.41 14.74 36 33066 88441 34835388
Renal impairment 17.32 14.74 40 33062 94473 34829356
Embolia cutis medicamentosa 17.25 14.74 7 33095 232 34923597
Victim of crime 17.11 14.74 8 33094 375 34923454
Hyperglycaemia 17.06 14.74 8 33094 39472 34884357
Application site ulcer 16.87 14.74 4 33098 19 34923810
Multiple cardiac defects 16.75 14.74 5 33097 64 34923765
Psychotic disorder 16.63 14.74 56 33046 24396 34899433
Anaphylactic reaction 16.54 14.74 5 33097 32296 34891533
Emotional poverty 16.46 14.74 9 33093 589 34923240
Disturbance in attention 16.41 14.74 58 33044 25887 34897942
Abdominal pain 16.11 14.74 90 33012 163528 34760301
Mental status changes 16.03 14.74 8 33094 38075 34885754
Deafness bilateral 15.85 14.74 11 33091 1103 34922726
Administration site abscess sterile 15.81 14.74 3 33099 3 34923826
Dermal absorption impaired 15.81 14.74 3 33099 3 34923826
Gun shot wound 15.72 14.74 11 33091 1117 34922712
Delusion 15.63 14.74 36 33066 12599 34911230
Dyspnoea exertional 15.53 14.74 11 33091 43268 34880561
Cataract 15.47 14.74 3 33099 26183 34897646
Drug reaction with eosinophilia and systemic symptoms 15.37 14.74 6 33096 33006 34890823
Incoherent 15.36 14.74 20 33082 4432 34919397
Rash maculo-papular 15.32 14.74 4 33098 28447 34895382
Selective eating disorder 15.26 14.74 13 33089 1765 34922064
Alcohol withdrawal syndrome 15.13 14.74 12 33090 1474 34922355
Injection site discolouration 15.08 14.74 12 33090 1481 34922348
Decreased appetite 15.07 14.74 94 33008 166298 34757531
Eschar 15.00 14.74 9 33093 703 34923126
Rectal haemorrhage 14.75 14.74 10 33092 40239 34883590

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
Drug abuse 2105.40 11.99 1303 49836 161388 79531861
Drug withdrawal syndrome 1627.02 11.99 667 50472 34051 79659198
Drug dependence 1175.73 11.99 557 50582 40212 79653037
Application site pruritus 1122.40 11.99 295 50844 3515 79689734
Product adhesion issue 990.12 11.99 249 50890 2455 79690794
Application site erythema 820.18 11.99 246 50893 4864 79688385
Toxicity to various agents 735.15 11.99 1110 50029 420430 79272819
Intentional product misuse 724.81 11.99 551 50588 94614 79598635
Substance abuse 671.17 11.99 253 50886 10273 79682976
Miosis 610.91 11.99 265 50874 15524 79677725
Application site rash 598.83 11.99 159 50980 1973 79691276
Application site pain 477.20 11.99 160 50979 4587 79688662
Application site burn 476.58 11.99 111 51028 764 79692485
Inadequate analgesia 473.18 11.99 158 50981 4471 79688778
Application site vesicles 445.71 11.99 116 51023 1324 79691925
Withdrawal syndrome 350.44 11.99 217 50922 26637 79666612
Respiratory depression 342.25 11.99 216 50923 27414 79665835
Overdose 339.53 11.99 499 50640 183707 79509542
Drug use disorder 301.62 11.99 135 51004 8516 79684733
Accidental overdose 298.31 11.99 228 50911 39353 79653896
Alcohol abuse 295.69 11.99 116 51023 5247 79688002
Coma 257.49 11.99 320 50819 100329 79592920
Somnolence 250.46 11.99 504 50635 238477 79454772
Asphyxia 200.90 11.99 113 51026 11607 79681642
Application site irritation 200.22 11.99 65 51074 1679 79691570
Application site scar 178.98 11.99 38 51101 159 79693090
Intentional product use issue 164.19 11.99 325 50814 151787 79541462
Application site dryness 159.95 11.99 36 51103 208 79693041
Accidental exposure to product by child 153.28 11.99 61 51078 2865 79690384
Drug interaction 151.58 11.99 596 50543 414587 79278662
Drug screen positive 139.17 11.99 71 51068 5992 79687257
Death 137.75 11.99 721 50418 565793 79127456
Application site discolouration 136.04 11.99 41 51098 823 79692426
Wrong technique in product usage process 134.21 11.99 199 50940 73676 79619573
Agitation 133.79 11.99 234 50905 99481 79593768
Application site discharge 131.09 11.99 33 51106 326 79692923
Accidental poisoning 124.65 11.99 45 51094 1612 79691637
Injection site ulcer 121.35 11.99 36 51103 683 79692566
Application site exfoliation 117.98 11.99 33 51106 503 79692746
Injection site abscess 117.63 11.99 43 51096 1597 79691652
Application site urticaria 116.95 11.99 28 51111 220 79693029
Drug detoxification 112.90 11.99 30 51109 373 79692876
Brain oedema 105.65 11.99 104 51035 25159 79668090
Application site erosion 103.00 11.99 26 51113 260 79692989
Drug delivery system removal 101.65 11.99 16 51123 0 79693249
Aggression 100.88 11.99 143 50996 50815 79642434
Injection site pain 97.58 11.99 240 50899 129598 79563651
Depressed level of consciousness 94.13 11.99 198 50941 96454 79596795
Blepharospasm 93.78 11.99 54 51085 5797 79687452
Injection site infection 91.68 11.99 39 51100 2173 79691076
Febrile neutropenia 90.28 11.99 19 51120 230980 79462269
Hyperhidrosis 87.51 11.99 254 50885 151238 79542011
Hyperaesthesia 86.79 11.99 68 51071 12154 79681095
Bradypnoea 84.26 11.99 51 51088 6001 79687248
Euphoric mood 82.37 11.99 55 51084 7671 79685578
Pyrexia 81.85 11.99 198 50941 678511 79014738
Taste disorder 79.27 11.99 72 51067 15751 79677498
Infusion related reaction 78.40 11.99 25 51114 230212 79463037
Diarrhoea 77.54 11.99 297 50842 880192 78813057
Logorrhoea 77.29 11.99 43 51096 4322 79688927
Drug screen negative 76.93 11.99 21 51118 291 79692958
Hepatitis C 75.43 11.99 62 51077 11863 79681386
Endocarditis staphylococcal 74.72 11.99 25 51114 711 79692538
Application site swelling 74.16 11.99 25 51114 728 79692521
Hallucination 73.63 11.99 167 50972 85578 79607671
Skin irritation 72.27 11.99 59 51080 11181 79682068
Arthropathy 70.37 11.99 14 51125 177097 79516152
Application site reaction 69.53 11.99 24 51115 752 79692497
Drug diversion 68.77 11.99 27 51112 1223 79692026
Pulmonary oedema 68.26 11.99 165 50974 88089 79605160
Product physical issue 68.07 11.99 39 51100 4146 79689103
Injection site necrosis 67.76 11.99 28 51111 1450 79691799
Maternal exposure during pregnancy 67.67 11.99 217 50922 136321 79556928
Poisoning 67.20 11.99 82 51057 25190 79668059
Disturbance in attention 65.24 11.99 117 51022 50684 79642565
Inappropriate schedule of product administration 64.98 11.99 211 50928 133417 79559832
Application site scab 64.53 11.99 17 51122 204 79693045
Synovitis 64.05 11.99 10 51129 150724 79542525
Drug withdrawal syndrome neonatal 63.71 11.99 18 51121 285 79692964
Joint swelling 63.52 11.99 55 51084 288591 79404658
Respiratory arrest 62.05 11.99 123 51016 57427 79635822
Product administered at inappropriate site 61.96 11.99 36 51103 3929 79689320
Suicidal ideation 60.41 11.99 144 50995 76196 79617053
Brachial artery entrapment syndrome 59.34 11.99 13 51126 65 79693184
Arthralgia 58.24 11.99 181 50958 571622 79121627
Disorientation 58.09 11.99 126 51013 62650 79630599
Intentional removal of drug delivery system by patient 57.18 11.99 9 51130 0 79693249
Treatment failure 57.16 11.99 19 51120 170467 79522782
Cough 57.06 11.99 92 51047 366697 79326552
Product solubility abnormal 57.03 11.99 22 51117 950 79692299
Platelet count decreased 56.59 11.99 27 51112 194637 79498612
Injection site erosion 56.59 11.99 14 51125 128 79693121
Cluster headache 56.51 11.99 22 51117 974 79692275
Stress cardiomyopathy 56.30 11.99 51 51088 11115 79682134
Compartment syndrome 56.16 11.99 37 51102 5045 79688204
Application site haemorrhage 55.88 11.99 24 51115 1369 79691880
Fatigue 55.66 11.99 359 50780 929368 78763881
Intentional underdose 55.29 11.99 28 51111 2326 79690923
White blood cell count decreased 53.39 11.99 27 51112 188261 79504988
Drug abuser 52.81 11.99 38 51101 5975 79687274
Application site ulcer 52.63 11.99 13 51126 118 79693131
Sinusitis 52.56 11.99 30 51109 195471 79497778
Neutropenia 50.79 11.99 66 51073 287644 79405605
Substance dependence 50.69 11.99 17 51122 487 79692762
Restlessness 49.67 11.99 99 51040 46393 79646856
Dysarthria 48.66 11.99 123 51016 67499 79625750
Unresponsive to stimuli 48.26 11.99 109 51030 55679 79637570
Sarcopenia 47.82 11.99 16 51123 455 79692794
Application site dermatitis 47.57 11.99 13 51126 181 79693068
Systemic lupus erythematosus 47.23 11.99 10 51129 121139 79572110
Myelopathy 47.04 11.99 32 51107 4601 79688648
Therapeutic product effect increased 46.85 11.99 22 51117 1549 79691700
Haemoglobin decreased 46.85 11.99 44 51095 222075 79471174
Pericarditis 46.42 11.99 6 51133 104230 79589019
Hand deformity 46.23 11.99 6 51133 103913 79589336
Pemphigus 46.16 11.99 5 51134 99577 79593672
Delirium 46.07 11.99 139 51000 84488 79608761
Infection 45.23 11.99 53 51086 241659 79451590
Defaecation disorder 45.21 11.99 17 51122 684 79692565
Application site odour 44.97 11.99 9 51130 26 79693223
Quadriparesis 44.91 11.99 28 51111 3473 79689776
Injection site extravasation 44.56 11.99 42 51097 9627 79683622
Substance use disorder 43.78 11.99 18 51121 920 79692329
Yawning 43.44 11.99 20 51119 1346 79691903
Dermo-hypodermitis 43.28 11.99 17 51122 771 79692478
Rheumatoid arthritis 43.14 11.99 42 51097 208428 79484821
Confusional state 42.12 11.99 348 50791 317649 79375600
Endocarditis 41.31 11.99 42 51097 10555 79682694
Epilepsy 41.26 11.99 85 51054 40775 79652474
Product dose omission issue 40.46 11.99 60 51079 247477 79445772
Breakthrough pain 40.43 11.99 19 51120 1340 79691909
Visceral congestion 40.10 11.99 17 51122 939 79692310
Swelling 40.03 11.99 48 51091 216663 79476586
Application site inflammation 39.92 11.99 14 51125 460 79692789
Pneumonia 39.90 11.99 254 50885 659992 79033257
Impaired reasoning 39.61 11.99 10 51129 100 79693149
Congenital coronary artery malformation 39.09 11.99 10 51129 106 79693143
Decreased gait velocity 38.71 11.99 11 51128 178 79693071
Interstitial lung disease 38.71 11.99 12 51127 112588 79580661
Subchondral insufficiency fracture 38.63 11.99 9 51130 62 79693187
17 ketosteroids urine abnormal 38.12 11.99 6 51133 0 79693249
Alopecia 37.89 11.99 56 51083 231299 79461950
Bradycardia foetal 37.66 11.99 10 51129 124 79693125
Disease progression 37.16 11.99 38 51101 184324 79508925
Hypertension 37.12 11.99 100 51039 330892 79362357
Pneumonia aspiration 36.45 11.99 110 51029 66857 79626392
Altered state of consciousness 36.11 11.99 84 51055 43738 79649511
Impaired driving ability 36.03 11.99 29 51110 5386 79687863
COVID-19 35.95 11.99 29 51110 157645 79535604
Congenital multiplex arthrogryposis 35.86 11.99 7 51132 17 79693232
Deafness neurosensory 35.75 11.99 32 51107 6866 79686383
Rash 35.69 11.99 221 50918 578137 79115112
Incorrect route of product administration 35.67 11.99 73 51066 34856 79658393
Gastrointestinal disorder 35.43 11.99 17 51122 122188 79571061
Phlebotomy 35.04 11.99 9 51130 97 79693152
Thrombocytopenia 34.60 11.99 74 51065 265185 79428064
Product physical consistency issue 34.37 11.99 15 51124 890 79692359
Anti-cyclic citrullinated peptide antibody positive 34.23 11.99 6 51133 83137 79610112
Bradyphrenia 34.09 11.99 38 51101 10602 79682647
Substance use 33.91 11.99 15 51124 919 79692330
Injection site cellulitis 33.79 11.99 18 51121 1660 79691589
Herpes zoster 33.69 11.99 9 51130 93074 79600175
Dyspnoea 33.51 11.99 370 50769 856655 78836594
Aptyalism 33.41 11.99 14 51125 751 79692498
Paranoia 33.34 11.99 51 51088 19381 79673868
Application site pustules 32.83 11.99 7 51132 30 79693219
Injection site discharge 32.44 11.99 14 51125 808 79692441
Contraindicated product administered 32.29 11.99 32 51107 157506 79535743
Mucosal inflammation 32.13 11.99 5 51134 75575 79617674
Off label use 31.88 11.99 401 50738 906814 78786435
Product substitution issue 31.75 11.99 51 51088 20205 79673044
Weight increased 31.70 11.99 83 51056 277303 79415946
Hypersensitivity 31.10 11.99 77 51062 262162 79431087
Loss of consciousness 30.96 11.99 199 50940 167744 79525505
Vestibular ischaemia 30.90 11.99 6 51133 14 79693235
Dermatitis contact 29.65 11.99 36 51103 10997 79682252
Exposure during pregnancy 29.61 11.99 136 51003 100996 79592253
Hallucination, visual 29.48 11.99 65 51074 32664 79660585
Echocardiogram abnormal 29.04 11.99 18 51121 2210 79691039
Musculoskeletal stiffness 29.00 11.99 42 51097 174966 79518283
Poisoning deliberate 28.96 11.99 47 51092 18781 79674468
Hypertonia 28.80 11.99 29 51110 7203 79686046
Housebound 28.74 11.99 11 51128 465 79692784
Application site hypersensitivity 28.65 11.99 10 51129 324 79692925
Ear deformity acquired 28.30 11.99 5 51134 5 79693244
Glossodynia 27.56 11.99 16 51123 103321 79589928
Nasopharyngitis 27.48 11.99 78 51061 253803 79439446
Aspartate aminotransferase increased 27.46 11.99 29 51110 138612 79554637
Abnormal behaviour 26.98 11.99 67 51072 36354 79656895
Pulmonary congestion 26.92 11.99 56 51083 27044 79666205
Psychomotor skills impaired 26.56 11.99 24 51115 5213 79688036
Hepatic enzyme increased 26.34 11.99 48 51091 182562 79510687
Sedation 26.16 11.99 83 51056 51812 79641437
Neurosis 26.03 11.99 10 51129 427 79692822
Persecutory delusion 25.89 11.99 23 51116 4886 79688363
Glomerulonephritis acute 25.89 11.99 9 51130 288 79692961
Product packaging quantity issue 25.84 11.99 14 51125 1335 79691914
Congestive hepatopathy 25.38 11.99 22 51117 4525 79688724
Eyelid retraction 25.31 11.99 6 51133 45 79693204
Blood glucose increased 25.15 11.99 22 51117 114953 79578296
Bronchitis 25.12 11.99 28 51111 130616 79562633
Sinus arrhythmia 24.88 11.99 16 51123 2094 79691155
Product dispensing issue 24.77 11.99 8 51131 203 79693046
Helicobacter infection 24.74 11.99 7 51132 69697 79623552
Duodenal ulcer perforation 24.73 11.99 6 51133 66205 79627044
Feeling drunk 24.67 11.99 22 51117 4697 79688552
Respiratory acidosis 24.51 11.99 33 51106 11167 79682082
Accidental death 24.43 11.99 21 51118 4270 79688979
Neutrophil count decreased 24.42 11.99 15 51124 93944 79599305
Micrognathia 24.37 11.99 5 51134 17 79693232
Neuropathy peripheral 24.32 11.99 33 51106 141272 79551977
Vomiting 24.24 11.99 578 50561 665250 79027999
Alcohol interaction 24.06 11.99 22 51117 4852 79688397
Faecaloma 23.69 11.99 33 51106 11531 79681718
Influenza 23.61 11.99 29 51110 129577 79563672
Atrial fibrillation 23.54 11.99 58 51081 197828 79495421
Chronic actinic dermatitis 23.53 11.99 5 51134 21 79693228
Anxiety 23.38 11.99 253 50886 248259 79444990
Application site induration 23.17 11.99 4 51135 3 79693246
Injection site oedema 22.90 11.99 13 51126 1358 79691891
Wrong dose 22.88 11.99 14 51125 1680 79691569
Asthenia 22.79 11.99 214 50925 511475 79181774
Cardiac failure congestive 22.79 11.99 35 51104 142367 79550882
Application site papules 22.77 11.99 6 51133 72 79693177
Tachyphrenia 22.64 11.99 15 51124 2065 79691184
Pain in extremity 22.08 11.99 140 50999 364398 79328851
Anaemia 22.07 11.99 181 50958 444834 79248415
Vulvar basal cell carcinoma 22.05 11.99 5 51134 30 79693219
Injection site erythema 22.04 11.99 104 51035 78093 79615156
Maternal use of illicit drugs 21.75 11.99 4 51135 6 79693243
Nasal congestion 21.65 11.99 11 51128 76541 79616708
Premature delivery 21.58 11.99 47 51092 23420 79669829
Cerebrovascular accident 21.36 11.99 42 51097 155250 79537999
Prescription drug used without a prescription 21.27 11.99 19 51120 4066 79689183
Mastication disorder 21.24 11.99 16 51123 2697 79690552
Blood cholesterol increased 20.89 11.99 14 51125 83706 79609543
Victim of sexual abuse 20.80 11.99 9 51130 523 79692726
Coronary artery disease 20.74 11.99 8 51131 65466 79627783
Haematocrit decreased 20.25 11.99 7 51132 61305 79631944
Hypoventilation 20.11 11.99 24 51115 7200 79686049
Psoriasis 19.77 11.99 17 51122 89570 79603679
Injection site inflammation 19.73 11.99 18 51121 3958 79689291
Memory impairment 19.73 11.99 131 51008 111603 79581646
Dementia with Lewy bodies 19.68 11.99 10 51129 836 79692413
Expulsion of medication 19.63 11.99 5 51134 52 79693197
Troponin T increased 19.58 11.99 17 51122 3505 79689744
Rhabdomyolysis 19.49 11.99 123 51016 103008 79590241
Malignant neoplasm progression 19.38 11.99 36 51103 135954 79557295
Pancytopenia 19.38 11.99 49 51090 165696 79527553
Cyanosis 19.37 11.99 47 51092 25135 79668114
Upper respiratory tract infection 19.28 11.99 18 51121 91150 79602099
Emotional poverty 19.24 11.99 10 51129 877 79692372
Urticaria 19.23 11.99 58 51081 185143 79508106
Application site bruise 19.20 11.99 7 51132 258 79692991
Tachycardia 19.11 11.99 186 50953 177582 79515667
Oral administration complication 19.10 11.99 6 51133 139 79693110
Foetal non-stress test abnormal 19.06 11.99 3 51136 0 79693249
Pupil constriction procedure 19.06 11.99 3 51136 0 79693249
Drug hypersensitivity 19.03 11.99 113 51026 298803 79394446
Respiratory rate decreased 19.03 11.99 20 51119 5223 79688026
Persistent depressive disorder 18.99 11.99 11 51128 1194 79692055
Suicide attempt 18.96 11.99 104 51035 82828 79610421
Muscle injury 18.94 11.99 4 51135 48557 79644692
Dysphoria 18.88 11.99 19 51120 4715 79688534
Folliculitis 18.85 11.99 6 51133 55374 79637875
Venous thrombosis 18.77 11.99 23 51116 7093 79686156
Adrenergic syndrome 18.70 11.99 6 51133 149 79693100
Substance abuser 18.70 11.99 6 51133 149 79693100
Dyspnoea exertional 18.64 11.99 17 51122 87056 79606193
Therapy non-responder 18.62 11.99 19 51120 92286 79600963
Reaction to excipient 18.61 11.99 12 51127 1577 79691672
Abdominal discomfort 18.61 11.99 90 51049 250637 79442612
Electrocardiogram T wave alternans 18.54 11.99 5 51134 66 79693183
Cardio-respiratory arrest 18.43 11.99 126 51013 108384 79584865
Injection site ischaemia 18.43 11.99 4 51135 19 79693230
Therapy naive 18.40 11.99 5 51134 68 79693181
Diabetes mellitus 18.39 11.99 14 51125 78376 79614873
Radial nerve palsy 18.29 11.99 8 51131 477 79692772
Serotonin syndrome 18.28 11.99 67 51072 44960 79648289
Application site perspiration 18.26 11.99 4 51135 20 79693229
Stomatitis 18.25 11.99 42 51097 146715 79546534
Psoriatic arthropathy 18.21 11.99 14 51125 77985 79615264
Vestibular disorder 18.17 11.99 14 51125 2441 79690808
Mydriasis 18.16 11.99 37 51102 17606 79675643
Brief psychotic disorder with marked stressors 18.15 11.99 7 51132 302 79692947
Haemorrhage 18.10 11.99 19 51120 91099 79602150
Type 2 diabetes mellitus 18.06 11.99 7 51132 57115 79636134
Constipation 18.01 11.99 268 50871 282782 79410467
Delusion 17.76 11.99 40 51099 20383 79672866
Clostridium difficile infection 17.75 11.99 3 51136 42682 79650567
Pleural effusion 17.72 11.99 42 51097 145220 79548029
Irritable bowel syndrome 17.52 11.99 9 51130 62232 79631017
Cataract 17.46 11.99 9 51130 62111 79631138
Foetal exposure during pregnancy 17.39 11.99 20 51119 5770 79687479
Product preparation error 17.39 11.99 20 51119 5773 79687476
Incoherent 17.35 11.99 23 51116 7669 79685580
Application site infection 17.05 11.99 5 51134 91 79693158
Administration site abscess sterile 16.98 11.99 3 51136 3 79693246
Cerebral vasoconstriction 16.97 11.99 11 51128 1459 79691790
Cryoglobulinaemia 16.95 11.99 9 51130 824 79692425
Pancreatic steatosis 16.85 11.99 10 51129 1135 79692114
Intervertebral discitis 16.78 11.99 18 51121 4810 79688439
Throat irritation 16.76 11.99 3 51136 40943 79652306
Tooth hypoplasia 16.72 11.99 6 51133 211 79693038
Adverse drug reaction 16.70 11.99 11 51128 66381 79626868
Haematemesis 16.59 11.99 72 51067 52192 79641057
Abortion spontaneous 16.55 11.99 49 51090 29458 79663791
Apnoea 16.37 11.99 28 51111 11676 79681573
Epistaxis 16.36 11.99 29 51110 111486 79581763
Hyponatraemia 16.19 11.99 59 51080 177789 79515460
Myocardial infarction 16.17 11.99 62 51077 184067 79509182
Chronic hepatitis C 16.02 11.99 8 51131 645 79692604
Knee arthroplasty 15.99 11.99 4 51135 43244 79650005
Faeces soft 15.94 11.99 23 51116 8300 79684949
Allodynia 15.83 11.99 11 51128 1637 79691612
Blood creatinine increased 15.78 11.99 49 51090 155008 79538241
Bruxism 15.77 11.99 16 51123 4010 79689239
Drug reaction with eosinophilia and systemic symptoms 15.68 11.99 11 51128 64233 79629016
Judgement impaired 15.68 11.99 10 51129 1290 79691959
Weight decreased 15.60 11.99 149 50990 355049 79338200
Sepsis 15.53 11.99 105 51034 269323 79423926
Genitourinary symptom 15.47 11.99 6 51133 263 79692986
Product odour abnormal 15.38 11.99 10 51129 1334 79691915
Victim of crime 15.07 11.99 7 51132 481 79692768
Urinary incontinence 15.06 11.99 59 51080 40850 79652399
Heart rate abnormal 15.05 11.99 19 51120 6038 79687211
Cystic lymphangioma 14.91 11.99 3 51136 9 79693240
Productive cough 14.82 11.99 21 51118 88310 79604939
Lactic acidosis 14.75 11.99 14 51125 70345 79622904
Basal cell carcinoma 14.74 11.99 3 51136 37372 79655877
Ascites 14.74 11.99 16 51123 75546 79617703
Injection site irritation 14.73 11.99 15 51124 3775 79689474
Oropharyngeal pain 14.67 11.99 30 51109 109323 79583926
Repetitive strain injury 14.63 11.99 5 51134 152 79693097
Hallucinations, mixed 14.60 11.99 20 51119 6879 79686370
Condition aggravated 14.51 11.99 230 50909 500894 79192355
Migraine 14.50 11.99 101 51038 87392 79605857
Chest discomfort 14.50 11.99 43 51096 138001 79555248
Adjacent segment degeneration 14.24 11.99 3 51136 12 79693237
Ankyloglossia congenital 14.24 11.99 3 51136 12 79693237
Blood potassium decreased 14.21 11.99 6 51133 46506 79646743
Gastrointestinal haemorrhage 14.12 11.99 48 51091 147671 79545578
Dependence 14.09 11.99 12 51127 2410 79690839
Hyperkalaemia 14.01 11.99 33 51106 114365 79578884
Conjunctival haemorrhage 13.95 11.99 18 51121 5847 79687402
Diverticulitis 13.92 11.99 6 51133 45930 79647319
Accidental exposure to product 13.91 11.99 48 51091 31274 79661975
Intentional misuse of drug delivery system 13.86 11.99 3 51136 14 79693235
Hip arthroplasty 13.83 11.99 3 51136 35753 79657496
Testicular pain 13.61 11.99 11 51128 2054 79691195
Blood pressure decreased 13.59 11.99 27 51112 99439 79593810
Product contamination 13.50 11.99 9 51130 1251 79691998
Injection site vesicles 13.50 11.99 13 51126 3059 79690190
Intentional overdose 13.48 11.99 115 51024 105845 79587404
Cardiogenic shock 13.47 11.99 5 51134 41909 79651340
Bladder dilatation 13.36 11.99 11 51128 2108 79691141
Placental disorder 13.34 11.99 8 51131 925 79692324
Maternal drugs affecting foetus 13.34 11.99 10 51129 1673 79691576
Embolia cutis medicamentosa 13.31 11.99 7 51132 629 79692620
Viral titre decreased 13.23 11.99 3 51136 18 79693231
Developmental hip dysplasia 13.23 11.99 5 51134 204 79693045
Rash maculo-papular 13.17 11.99 10 51129 56068 79637181
Mixed anxiety and depressive disorder 12.99 11.99 6 51133 407 79692842
Dermal absorption impaired 12.96 11.99 3 51136 20 79693229
Lack of application site rotation 12.93 11.99 4 51135 88 79693161
Eye pain 12.92 11.99 4 51135 37574 79655675
Pharyngitis streptococcal 12.89 11.99 24 51115 10690 79682559
Ill-defined disorder 12.79 11.99 14 51125 65861 79627388
Arthritis 12.64 11.99 35 51104 114845 79578404
Pericardial effusion 12.55 11.99 7 51132 46230 79647019
Patient uncooperative 12.55 11.99 7 51132 707 79692542
Gastric cyst 12.52 11.99 4 51135 98 79693151
Lividity 12.46 11.99 6 51133 447 79692802
Psychotic disorder 12.35 11.99 56 51083 41346 79651903
Drug dependence, antepartum 12.27 11.99 3 51136 26 79693223
Kleptomania 12.27 11.99 3 51136 26 79693223
Urinary retention 12.26 11.99 70 51069 56560 79636689
Discoloured vomit 12.21 11.99 9 51130 1469 79691780
Tricuspid valve replacement 12.17 11.99 3 51136 27 79693222
Chest pain 12.15 11.99 119 51020 282185 79411064
Incorrect product administration duration 12.12 11.99 25 51114 11997 79681252
Urinary tract infection 12.11 11.99 115 51024 274397 79418852
Muscle rigidity 12.10 11.99 34 51105 19848 79673401
Cytokine release syndrome 12.08 11.99 4 51135 35994 79657255
False positive investigation result 12.05 11.99 8 51131 1104 79692145
Abdominal distension 12.04 11.99 38 51101 119612 79573637
Proteinuria 12.03 11.99 3 51136 32499 79660750

FDA Adverse Event Reporting System (Pediatric)

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
Drug withdrawal syndrome neonatal 58.63 35.09 43 167 2076 87506
Poor feeding infant 38.65 35.09 13 197 97 89485

Pharmacologic Action:

SourceCodeDescription
ATC N02AE01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Oripavine derivatives
ATC N07BC01 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
ATC N07BC51 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
CHEBI has role CHEBI:35482 narcotic analgesic
CHEBI has role CHEBI:55322 mu-opioid agonists
CHEBI has role CHEBI:59283 delta-opioid antagonists
CHEBI has role CHEBI:167165 kappa-opioid receptor antagonists
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009292 Narcotic Antagonists
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA MoA N0000175685 Partial Opioid Agonists
FDA EPC N0000175689 Partial Opioid Agonist
CHEBI has role CHEBI:59282 kappa-opioid receptor agonists

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

DiseaseRelationSNOMED_IDDOID
Opioid dependence indication 75544000 DOID:2559
Severe pain indication 76948002
Chronic pain indication 82423001
Prevention of opioid abuse indication 426928008
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Opioid withdrawal off-label use 87132004
Dependent drug abuse contraindication 6525002
Alcohol withdrawal delirium contraindication 8635005
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Chronic disease of respiratory system contraindication 17097001
Alcohol intoxication contraindication 25702006
Orthostatic hypotension contraindication 28651003
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Hypothyroidism contraindication 40930008 DOID:1459
Paralytic ileus contraindication 55525008 DOID:8442
Chronic type B viral hepatitis contraindication 61977001
Benign intracranial hypertension contraindication 68267002 DOID:11459
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Benign prostatic hyperplasia contraindication 266569009
Lesion of brain contraindication 301766008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Hypoxia contraindication 389086002
Respiratory insufficiency contraindication 409623005
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Kyphoscoliosis with Respiratory Compromise contraindication
Pain in Opioid Naive Patients contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Postoperative pain associated with surgical procedures Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Simbadol Zoetis Inc. 1
Zorbium Elanco US Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.97 acidic
pKa2 8.88 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8603514 April 3, 2024 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8603514 April 3, 2024 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8603514 April 3, 2024 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8603514 April 3, 2024 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 80MG BASE/IMPLANT PROBUPHINE TITAN PHARMS N204442 May 26, 2016 DISCN IMPLANT IMPLANTATION 7736665 April 25, 2024 FOR OPIOID DEPENDENCE
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8545832 June 6, 2025 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236755 July 31, 2026 A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8236292 Jan. 10, 2027 A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
EQ 2.1MG BASE;EQ 0.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2.1MG BASE;EQ 0.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 DISCN FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 8147866 July 23, 2027 TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9655843 July 23, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV OREXO US INC N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV OREXO US INC N204242 June 4, 2015 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8658198 Dec. 3, 2027 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 9687454 Aug. 7, 2029 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2MG BASE;EQ 0.5MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 8475832 March 26, 2030 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV OREXO US INC N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV OREXO US INC N204242 June 4, 2015 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 8470361 May 22, 2030 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10198218 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10592168 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9498432 June 6, 2031 IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10198218 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10592168 June 6, 2031 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9272044 June 6, 2031 TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9498432 June 6, 2031 IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9782402 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9827241 June 6, 2031 TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8975270 Sept. 5, 2031 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10912772 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11110084 July 26, 2032 A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 9937164 July 26, 2032 A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
EQ 0.7MG BASE;EQ 0.18MG BASE ZUBSOLV OREXO US INC N204242 Oct. 4, 2016 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV OREXO US INC N204242 June 4, 2015 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV OREXO US INC N204242 June 4, 2015 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE ZUBSOLV OREXO US INC N204242 June 4, 2015 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE ZUBSOLV OREXO US INC N204242 July 3, 2013 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020387 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11020388 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE ZUBSOLV OREXO US INC N204242 Dec. 11, 2014 RX TABLET SUBLINGUAL 11433066 Sept. 18, 2032 USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 9901539 Dec. 21, 2032 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 10646484 June 22, 2038 TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
128MG/0.36ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
16MG/0.32ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
24MG/0.48ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
32MG/0.64ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
64MG/0.18ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
8MG/0.16ML (50MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT
96MG/0.27ML (356MG/ML) BRIXADI BRAEBURN N210136 May 23, 2023 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS May 23, 2026 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Kappa-type opioid receptor GPCR ANTAGONIST Ki 9.01 WOMBAT-PK CHEMBL
Mu-type opioid receptor GPCR PARTIAL AGONIST Ki 8.29 WOMBAT-PK CHEMBL
Delta-type opioid receptor GPCR ANTAGONIST Ki 8.07 WOMBAT-PK
Nociceptin receptor GPCR Ki 7.11 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.10 CHEMBL
Mu-type opioid receptor GPCR Ki 9.89 CHEMBL
Mu-type opioid receptor GPCR Ki 9.40 CHEMBL
Delta-type opioid receptor GPCR Ki 9.32 CHEMBL
Kappa-type opioid receptor GPCR Ki 9.30 CHEMBL

External reference:

IDSource
4019644 VUID
N0000147737 NUI
D00836 KEGG_DRUG
53152-21-9 SECONDARY_CAS_RN
1819 RXNORM
C0006405 UMLSCUI
CHEBI:3216 CHEBI
CHEMBL560511 ChEMBL_ID
CHEMBL511142 ChEMBL_ID
CHEMBL2368861 ChEMBL_ID
D002047 MESH_DESCRIPTOR_UI
DB00921 DRUGBANK_ID
1670 IUPHAR_LIGAND_ID
3403 INN_ID
40D3SCR4GZ UNII
644073 PUBCHEM_CID
11186 MMSL
257949 MMSL
27271 MMSL
31700 MMSL
4306 MMSL
d00840 MMSL
21066009 SNOMEDCT_US
31684002 SNOMEDCT_US
387173000 SNOMEDCT_US
4018880 VANDF
4019644 VANDF
001573 NDDF
004632 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3239 PATCH, EXTENDED RELEASE 7.50 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3239 PATCH, EXTENDED RELEASE 7.50 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3656 PATCH, EXTENDED RELEASE 5 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3656 PATCH, EXTENDED RELEASE 5 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3657 PATCH, EXTENDED RELEASE 10 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3657 PATCH, EXTENDED RELEASE 10 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3658 PATCH, EXTENDED RELEASE 15 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3658 PATCH, EXTENDED RELEASE 15 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3659 PATCH, EXTENDED RELEASE 20 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3659 PATCH, EXTENDED RELEASE 20 ug TRANSDERMAL ANDA 31 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0121-1018 TABLET 2 mg SUBLINGUAL ANDA 31 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0121-2036 TABLET 8 mg SUBLINGUAL ANDA 31 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 16 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 16 sections