buprenorphine 🐶 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
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 µM/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 Società 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 1699.40 13.16 404 29773 3355 50571592
Product adhesion issue 1682.47 13.16 413 29764 3979 50570968
Drug withdrawal syndrome 1387.46 13.16 532 29645 24549 50550398
Application site erythema 1187.80 13.16 315 29862 4223 50570724
Application site rash 929.44 13.16 227 29950 2130 50572817
Inadequate analgesia 719.17 13.16 188 29989 2370 50572577
Application site pain 699.08 13.16 200 29977 3598 50571349
Application site vesicles 697.96 13.16 162 30015 1193 50573754
Application site burn 558.81 13.16 122 30055 654 50574293
Drug withdrawal syndrome neonatal 458.76 13.16 123 30054 1718 50573229
Drug abuse 421.16 13.16 321 29856 59525 50515422
Drug dependence 398.70 13.16 207 29970 19552 50555395
Application site irritation 360.77 13.16 99 30078 1516 50573431
Maternal exposure during pregnancy 345.98 13.16 450 29727 159328 50415619
Foetal exposure during pregnancy 242.80 13.16 169 30008 27190 50547757
Wrong technique in product usage process 241.85 13.16 226 29951 55284 50519663
Application site scar 233.35 13.16 48 30129 182 50574765
Exposure during pregnancy 228.29 13.16 319 29858 120696 50454251
Application site discharge 224.93 13.16 44 30133 120 50574827
Substance abuse 211.64 13.16 83 30094 4041 50570906
Application site erosion 201.33 13.16 41 30136 146 50574801
Application site exfoliation 187.61 13.16 42 30135 257 50574690
Application site dryness 181.42 13.16 37 30140 133 50574814
Application site discolouration 167.61 13.16 46 30131 704 50574243
Premature delivery 144.77 13.16 117 30060 23546 50551401
Withdrawal syndrome 142.92 13.16 103 30074 17487 50557460
Application site urticaria 138.48 13.16 32 30145 230 50574717
Product solubility abnormal 122.25 13.16 36 30141 718 50574229
Abortion spontaneous 121.67 13.16 137 30040 41635 50533312
Product physical issue 118.90 13.16 56 30121 4276 50570671
Application site swelling 113.40 13.16 31 30146 467 50574480
Application site reaction 112.88 13.16 33 30144 641 50574306
Product packaging quantity issue 109.51 13.16 36 30141 1044 50573903
Inappropriate schedule of product administration 103.32 13.16 167 30010 71664 50503283
Product administered at inappropriate site 100.66 13.16 42 30135 2401 50572546
Placental disorder 95.89 13.16 35 30142 1395 50573552
Hyperhidrosis 95.02 13.16 182 29995 89244 50485703
Respiratory depression 92.27 13.16 68 30109 11942 50563005
Overdose 91.62 13.16 191 29986 99536 50475411
Placental hypertrophy 89.96 13.16 14 30163 0 50574947
Therapeutic product effect increased 87.69 13.16 30 30147 986 50573961
Somnolence 84.71 13.16 243 29934 154742 50420205
Drug screen positive 84.31 13.16 41 30136 3361 50571586
Jaundice neonatal 82.10 13.16 27 30150 784 50574163
Maternal exposure during breast feeding 79.99 13.16 39 30138 3215 50571732
Toxicity to various agents 76.43 13.16 289 29888 212210 50362737
Intentional product misuse 76.00 13.16 115 30062 46619 50528328
Accidental exposure to product by child 71.76 13.16 26 30151 1014 50573933
Oral administration complication 71.04 13.16 16 30161 101 50574846
Drug delivery system removal 70.68 13.16 11 30166 0 50574947
Product physical consistency issue 69.85 13.16 21 30156 451 50574496
Abortion induced 69.75 13.16 52 30125 9292 50565655
Hyperaesthesia 69.00 13.16 49 30128 8124 50566823
Injection site pain 68.47 13.16 182 29995 110842 50464105
Application site ulcer 67.68 13.16 15 30162 87 50574860
Exposure via breast milk 67.45 13.16 28 30149 1580 50573367
Euphoric mood 66.37 13.16 37 30140 4018 50570929
Yawning 63.17 13.16 23 30154 910 50574037
Application site scab 63.16 13.16 16 30161 176 50574771
Arthropathy 61.86 13.16 10 30167 157896 50417051
Blepharospasm 59.74 13.16 31 30146 2917 50572030
Systemic lupus erythematosus 59.57 13.16 7 30170 140615 50434332
Application site dermatitis 59.29 13.16 15 30162 164 50574783
Drug use disorder 58.53 13.16 31 30146 3041 50571906
Treatment failure 57.94 13.16 7 30170 137630 50437317
Rhesus incompatibility 57.86 13.16 13 30164 81 50574866
Drug screen negative 57.75 13.16 16 30161 254 50574693
Injection site extravasation 56.56 13.16 42 30135 7459 50567488
Injection site infection 56.50 13.16 25 30152 1651 50573296
Selective abortion 55.85 13.16 14 30163 147 50574800
Sinusitis 54.42 13.16 17 30160 170541 50404406
Infusion related reaction 53.92 13.16 17 30160 169540 50405407
Stress cardiomyopathy 52.50 13.16 41 30136 7846 50567101
Breakthrough pain 51.74 13.16 21 30156 1118 50573829
Application site haemorrhage 50.92 13.16 20 30157 977 50573970
Alopecia 49.49 13.16 44 30133 245003 50329944
Hallucination 48.34 13.16 94 30083 46563 50528384
Pyrexia 47.65 13.16 97 30080 380106 50194841
Foetal growth restriction 47.51 13.16 36 30141 6591 50568356
Product dispensing issue 47.37 13.16 11 30166 81 50574866
Miosis 46.84 13.16 35 30142 6275 50568672
Device leakage 46.77 13.16 34 30143 5844 50569103
Contraindicated product administered 45.49 13.16 16 30161 148942 50426005
Joint swelling 44.95 13.16 48 30129 245238 50329709
Fatigue 44.84 13.16 244 29933 707357 49867590
Swelling 44.37 13.16 33 30144 200839 50374108
Taste disorder 44.33 13.16 38 30139 8286 50566661
Disturbance in attention 42.76 13.16 71 30106 31115 50543832
Drug detoxification 41.95 13.16 11 30166 140 50574807
Diarrhoea 41.75 13.16 195 29982 588281 49986666
Intentional underdose 41.55 13.16 20 30157 1602 50573345
Alcohol abuse 41.44 13.16 21 30156 1880 50573067
Drug diversion 41.38 13.16 16 30161 749 50574198
Subchondral insufficiency fracture 41.25 13.16 9 30168 48 50574899
Injection site cellulitis 41.14 13.16 18 30159 1157 50573790
Nasopharyngitis 40.95 13.16 33 30144 192894 50382053
Rheumatoid arthritis 40.13 13.16 37 30140 202513 50372434
Bradycardia foetal 39.51 13.16 13 30164 378 50574569
Dermatitis contact 39.13 13.16 36 30141 8610 50566337
17 ketosteroids urine abnormal 38.55 13.16 6 30171 0 50574947
Suicidal ideation 38.46 13.16 95 30082 55290 50519657
Impaired reasoning 38.21 13.16 9 30168 71 50574876
Application site odour 38.16 13.16 8 30169 34 50574913
Low birth weight baby 37.91 13.16 30 30147 5851 50569096
Prescription drug used without a prescription 37.70 13.16 19 30158 1681 50573266
Abdominal discomfort 37.45 13.16 50 30127 231591 50343356
Infection 37.43 13.16 29 30148 172925 50402022
Poor feeding infant 36.73 13.16 11 30166 233 50574714
Hepatic enzyme increased 36.71 13.16 18 30159 137362 50437585
Application site induration 36.12 13.16 6 30171 3 50574944
Accidental overdose 35.99 13.16 51 30126 19482 50555465
Application site inflammation 35.83 13.16 12 30165 369 50574578
Cough 35.16 13.16 56 30121 241208 50333739
Arthralgia 34.96 13.16 139 30038 438563 50136384
Glossodynia 34.29 13.16 13 30164 115556 50459391
Respiratory arrest 34.22 13.16 63 30114 29946 50545001
Therapy naive 33.16 13.16 7 30170 31 50574916
Neutropenia 33.06 13.16 24 30153 147941 50427006
Off label use 31.97 13.16 160 30017 474266 50100681
Skin irritation 30.82 13.16 30 30147 7697 50567250
Application site bruise 30.32 13.16 10 30167 293 50574654
Injection site abscess 30.14 13.16 14 30163 1035 50573912
Premature baby 29.62 13.16 45 30132 18292 50556655
Epilepsy 29.43 13.16 49 30128 21518 50553429
Application site papules 29.31 13.16 7 30170 59 50574888
Haemoglobin decreased 29.25 13.16 20 30157 127196 50447751
Febrile neutropenia 28.94 13.16 11 30166 97656 50477291
Platelet count decreased 28.78 13.16 12 30165 100714 50474233
White blood cell count decreased 28.69 13.16 17 30160 116705 50458242
Product colour issue 27.61 13.16 11 30166 558 50574389
Foetal malformation 27.19 13.16 8 30169 159 50574788
Monoplegia 26.57 13.16 18 30159 2765 50572182
Therapeutic response shortened 26.36 13.16 27 30150 7362 50567585
Unresponsive to stimuli 26.19 13.16 57 30120 30552 50544395
Eyelid retraction 26.10 13.16 6 30171 42 50574905
Faecaloma 25.41 13.16 26 30151 7082 50567865
Pneumonia 24.67 13.16 129 30048 378272 50196675
Maternal drugs affecting foetus 24.67 13.16 22 30155 5055 50569892
Dermatitis allergic 24.60 13.16 34 30143 12686 50562261
Defaecation disorder 24.59 13.16 10 30167 535 50574412
Genitourinary symptom 24.57 13.16 6 30171 56 50574891
Thrombocytopenia 24.47 13.16 24 30153 127649 50447298
Gastrointestinal disorder 24.30 13.16 13 30164 94443 50480504
Neurosis 24.11 13.16 8 30169 239 50574708
Judgement impaired 23.97 13.16 10 30167 571 50574376
Tooth hypoplasia 23.77 13.16 6 30171 65 50574882
Vulvar basal cell carcinoma 23.18 13.16 5 30172 25 50574922
Hypersensitivity 22.78 13.16 60 30117 215101 50359846
Extra dose administered 22.71 13.16 21 30156 5055 50569892
Musculoskeletal stiffness 22.56 13.16 26 30151 128455 50446492
Foetal death 22.39 13.16 26 30151 8154 50566793
Impaired healing 22.16 13.16 7 30170 69779 50505168
Product dose omission issue 22.05 13.16 48 30129 183790 50391157
Maternal use of illicit drugs 22.04 13.16 4 30173 6 50574941
Victim of sexual abuse 21.61 13.16 9 30168 512 50574435
Congenital coronary artery malformation 21.50 13.16 6 30171 98 50574849
Endocarditis staphylococcal 21.38 13.16 8 30169 342 50574605
Injection site ulcer 21.23 13.16 9 30168 535 50574412
Vomiting 20.88 13.16 388 29789 460370 50114577
Product contamination 20.83 13.16 9 30168 561 50574386
Hypertension 20.79 13.16 61 30116 211142 50363805
Somnolence neonatal 20.75 13.16 6 30171 112 50574835
Accidental poisoning 20.36 13.16 9 30168 593 50574354
Echocardiogram abnormal 20.26 13.16 11 30166 1134 50573813
Application site infection 19.90 13.16 5 30172 53 50574894
Sedation 19.67 13.16 51 30126 30559 50544388
Weight increased 19.38 13.16 59 30118 201832 50373115
Gastrointestinal hypomotility 19.36 13.16 10 30167 932 50574015
Product substitution issue 19.26 13.16 32 30145 14025 50560922
Neonatal aspiration 19.17 13.16 6 30171 148 50574799
Urinary incontinence 19.17 13.16 48 30129 28160 50546787
Small for dates baby 18.66 13.16 16 30161 3489 50571458
Focal segmental glomerulosclerosis 18.64 13.16 11 30166 1330 50573617
Radial nerve palsy 18.63 13.16 8 30169 491 50574456
Stillbirth 18.13 13.16 20 30157 5932 50569015
Injection site erosion 17.95 13.16 5 30172 81 50574866
Enlarged uvula 17.93 13.16 6 30171 184 50574763
Injection site oedema 17.92 13.16 10 30167 1088 50573859
Product prescribing error 17.89 13.16 39 30138 20922 50554025
Nausea 17.86 13.16 548 29629 704850 49870097
Agitation 17.81 13.16 71 30106 53313 50521634
Application site pustules 17.79 13.16 4 30173 25 50574922
Substance dependence 17.51 13.16 6 30171 198 50574749
Application site discomfort 17.37 13.16 7 30170 366 50574581
Hypersomnia 17.27 13.16 32 30145 15282 50559665
Confusional state 16.74 13.16 177 30000 185751 50389196
Blood cholesterol increased 16.72 13.16 6 30171 55209 50519738
Irritable bowel syndrome 16.62 13.16 5 30172 51436 50523511
Faeces soft 16.56 13.16 16 30161 4068 50570879
Ill-defined disorder 16.45 13.16 6 30171 54648 50520299
Bruxism 16.43 13.16 14 30163 3026 50571921
Cataract 16.40 13.16 4 30173 47296 50527651
Delirium 16.28 13.16 55 30122 38137 50536810
Application site laceration 15.98 13.16 3 30174 6 50574941
Application site perspiration 15.98 13.16 3 30174 6 50574941
Wound 15.92 13.16 24 30153 105770 50469177
Sinus arrhythmia 15.87 13.16 10 30167 1359 50573588
Pancytopenia 15.86 13.16 16 30161 84014 50490933
Dyspnoea 15.74 13.16 231 29946 547377 50027570
Interstitial lung disease 15.73 13.16 6 30171 53170 50521777
Depressed level of consciousness 15.68 13.16 67 30110 51886 50523061
Premature labour 15.56 13.16 26 30151 11450 50563497
Product odour abnormal 15.40 13.16 9 30168 1068 50573879
Condition aggravated 15.29 13.16 109 30068 296949 50277998
Disease progression 15.16 13.16 21 30156 95845 50479102
Product size issue 15.05 13.16 6 30171 305 50574642
Repetitive strain injury 14.89 13.16 5 30172 155 50574792
Lack of application site rotation 14.88 13.16 3 30174 10 50574937
Therapeutic response increased 14.84 13.16 6 30171 316 50574631
Migraine 14.83 13.16 86 30091 75194 50499753
Influenza 14.78 13.16 19 30158 89519 50485428
Therapy non-responder 14.69 13.16 6 30171 51016 50523931
Application site warmth 14.57 13.16 5 30172 166 50574781
Adjacent segment degeneration 14.46 13.16 3 30174 12 50574935
Femoral neck fracture 14.45 13.16 20 30157 7470 50567477
Oral mucosal blistering 14.37 13.16 16 30161 4796 50570151
Bradypnoea 14.30 13.16 13 30164 3061 50571886
Persistent depressive disorder 14.23 13.16 8 30169 883 50574064
Asthenia 14.12 13.16 122 30055 318920 50256027
Hepatitis C 14.09 13.16 16 30161 4901 50570046
Reversible cerebral vasoconstriction syndrome 14.07 13.16 11 30166 2108 50572839
Application site paraesthesia 14.02 13.16 4 30173 71 50574876
Neutrophil count decreased 13.94 13.16 5 30172 46021 50528926
Lack of administration site rotation 13.91 13.16 3 30174 15 50574932
Dental discomfort 13.90 13.16 6 30171 373 50574574
Feeling of body temperature change 13.87 13.16 15 30162 4352 50570595
Product preparation error 13.86 13.16 15 30162 4357 50570590
Injection site inflammation 13.84 13.16 13 30164 3192 50571755
Ankyloglossia congenital 13.70 13.16 5 30172 199 50574748
Product quality issue 13.65 13.16 45 30132 30813 50544134
Discoloured vomit 13.63 13.16 7 30170 644 50574303
Application site hypersensitivity 13.61 13.16 5 30172 203 50574744
Substance abuser 13.60 13.16 3 30174 17 50574930
Bronchitis 13.49 13.16 26 30151 104133 50470814
Mental disorder 13.48 13.16 36 30141 21955 50552992
Cystic lymphangioma 13.45 13.16 3 30174 18 50574929
Anaemia 13.30 13.16 92 30085 252364 50322583
Premature rupture of membranes 13.28 13.16 15 30162 4565 50570382
Restlessness 13.26 13.16 39 30138 25134 50549813
Dyspnoea exertional 13.25 13.16 7 30170 51226 50523721
Drug abuser 13.24 13.16 12 30165 2816 50572131
Learning disability 13.20 13.16 5 30172 221 50574726
Psoriasis 13.18 13.16 13 30164 68987 50505960

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 withdrawal syndrome 1636.29 14.24 624 27865 17360 29528678
Drug abuse 1434.74 14.24 913 27576 78970 29467068
Drug dependence 935.67 14.24 439 28050 20542 29525496
Intentional product misuse 738.66 14.24 443 28046 34218 29511820
Product adhesion issue 569.84 14.24 154 28335 1317 29544721
Drug withdrawal syndrome neonatal 513.34 14.24 172 28317 3223 29542815
Substance abuse 474.26 14.24 195 28294 6592 29539446
Miosis 469.20 14.24 203 28286 7806 29538232
Injection site pain 454.76 14.24 319 28170 32127 29513911
Toxicity to various agents 441.32 14.24 677 27812 172984 29373054
Application site pruritus 370.61 14.24 107 28382 1190 29544848
Intentional product use issue 308.06 14.24 284 28205 42214 29503824
Application site rash 286.58 14.24 78 28411 686 29545352
Application site erythema 284.51 14.24 98 28391 2001 29544037
Inadequate analgesia 273.05 14.24 101 28388 2553 29543485
Alcohol abuse 244.46 14.24 107 28382 4226 29541812
Overdose 230.21 14.24 331 28158 79488 29466550
Withdrawal syndrome 227.19 14.24 138 28351 10854 29535184
Drug use disorder 221.04 14.24 93 28396 3329 29542709
Foetal exposure during pregnancy 212.35 14.24 209 28280 33658 29512380
Application site burn 203.43 14.24 46 28443 166 29545872
Coma 197.89 14.24 216 28273 39234 29506804
Injection site infection 178.27 14.24 56 28433 845 29545193
Drug screen positive 170.50 14.24 80 28409 3721 29542317
Application site vesicles 165.06 14.24 47 28442 495 29545543
Respiratory depression 159.69 14.24 120 28369 13403 29532635
Injection site abscess 156.84 14.24 48 28441 661 29545377
Application site pain 151.29 14.24 58 28431 1621 29544417
Somnolence 150.79 14.24 300 28189 93655 29452383
Injection site ulcer 149.55 14.24 37 28452 213 29545825
Wrong technique in product usage process 143.68 14.24 164 28325 31264 29514774
Drug detoxification 138.97 14.24 33 28456 155 29545883
Injection site erythema 136.93 14.24 111 28378 13845 29532193
Accidental overdose 132.02 14.24 120 28369 17473 29528565
Drug delivery system removal 118.93 14.24 20 28469 0 29546038
Maternal exposure during breast feeding 108.19 14.24 44 28445 1442 29544596
Injection site extravasation 105.40 14.24 50 28439 2383 29543655
Asphyxia 100.31 14.24 63 28426 5252 29540786
Application site irritation 99.29 14.24 33 28456 601 29545437
Brain oedema 92.94 14.24 84 28405 12136 29533902
Drug screen negative 87.44 14.24 22 28467 137 29545901
Injection site erosion 84.36 14.24 19 28470 67 29545971
Febrile neutropenia 82.14 14.24 7 28482 112233 29433805
Agitation 81.17 14.24 163 28326 51141 29494897
Injection site necrosis 81.04 14.24 25 28464 354 29545684
Application site reaction 74.75 14.24 24 28465 390 29545648
Pyrexia 74.69 14.24 101 28388 287521 29258517
Jaundice neonatal 74.03 14.24 32 28457 1224 29544814
Euphoric mood 73.46 14.24 50 28439 4775 29541263
Accidental exposure to product by child 71.72 14.24 32 28457 1322 29544716
Brachial artery entrapment syndrome 71.36 14.24 12 28477 0 29546038
Aggression 71.26 14.24 125 28364 35416 29510622
Inappropriate schedule of product administration 71.18 14.24 142 28347 44330 29501708
Logorrhoea 69.59 14.24 37 28452 2251 29543787
Hyperhidrosis 67.47 14.24 174 28315 64366 29481672
Diarrhoea 66.80 14.24 138 28351 332560 29213478
Drug diversion 65.80 14.24 26 28463 789 29545249
Poor feeding infant 64.64 14.24 22 28467 432 29545606
Application site dryness 64.39 14.24 14 28475 40 29545998
Pneumonia 64.10 14.24 133 28356 320039 29225999
Prescription drug used without a prescription 63.31 14.24 29 28460 1275 29544763
Cluster headache 63.18 14.24 22 28467 464 29545574
Bradypnoea 62.83 14.24 35 28454 2336 29543702
Dysarthria 62.33 14.24 109 28380 30802 29515236
Congenital multiplex arthrogryposis 61.78 14.24 13 28476 30 29546008
Injection site vesicles 60.75 14.24 22 28467 522 29545516
Injection site discharge 60.67 14.24 15 28474 86 29545952
Atrial fibrillation 60.13 14.24 14 28475 105632 29440406
Intentional removal of drug delivery system by patient 59.46 14.24 10 28479 0 29546038
Dermo-hypodermitis 59.14 14.24 18 28471 243 29545795
Cough 57.60 14.24 25 28464 126702 29419336
Deafness neurosensory 54.87 14.24 33 28456 2545 29543493
Application site urticaria 54.41 14.24 13 28476 63 29545975
Platelet count decreased 53.69 14.24 17 28472 104655 29441383
Exposure via breast milk 52.96 14.24 28 28461 1684 29544354
Accidental poisoning 52.88 14.24 20 28469 538 29545500
Product dispensing issue 51.59 14.24 10 28479 12 29546026
Pulmonary oedema 50.74 14.24 121 28368 42614 29503424
Anaemia 50.63 14.24 72 28417 200879 29345159
Tremor neonatal 49.06 14.24 17 28472 353 29545685
Hypotension 48.60 14.24 70 28419 194284 29351754
Application site swelling 48.01 14.24 15 28474 222 29545816
Injection site cellulitis 47.52 14.24 18 28471 486 29545552
White blood cell count decreased 47.52 14.24 11 28478 83351 29462687
Drug abuser 47.48 14.24 35 28454 3792 29542246
Impaired driving ability 47.45 14.24 29 28460 2302 29543736
Therapeutic product effect increased 47.34 14.24 19 28470 601 29545437
Hepatitis C 46.73 14.24 50 28439 8860 29537178
Sarcopenia 45.57 14.24 16 28473 346 29545692
Injection site warmth 45.53 14.24 26 28463 1820 29544218
Low birth weight baby 45.53 14.24 43 28446 6565 29539473
Endocarditis staphylococcal 45.14 14.24 16 28473 356 29545682
Application site exfoliation 44.97 14.24 12 28477 97 29545941
Application site discolouration 44.64 14.24 14 28475 210 29545828
Injection site irritation 43.58 14.24 21 28468 1036 29545002
Disorientation 43.37 14.24 91 28398 29424 29516614
Premature baby 42.99 14.24 67 28422 17213 29528825
Poisoning 42.03 14.24 50 28439 9943 29536095
Cardiac failure congestive 41.91 14.24 11 28478 76570 29469468
Myelopathy 41.32 14.24 25 28464 1949 29544089
Therapeutic product effect decreased 41.19 14.24 89 28400 29362 29516676
Aptyalism 40.57 14.24 14 28475 287 29545751
Fatigue 40.32 14.24 163 28326 316658 29229380
Endocarditis 39.01 14.24 37 28452 5679 29540359
Application site hypersensitivity 38.79 14.24 11 28478 114 29545924
Application site erosion 38.61 14.24 10 28479 71 29545967
Product solubility abnormal 38.31 14.24 15 28474 444 29545594
Restlessness 38.19 14.24 73 28416 22072 29523966
Dyspnoea 37.96 14.24 174 28315 326558 29219480
Application site scar 37.86 14.24 8 28481 19 29546019
Oral administration complication 37.60 14.24 9 28480 44 29545994
Intentional underdose 37.14 14.24 16 28473 607 29545431
Product packaging quantity issue 37.10 14.24 17 28472 748 29545290
Decreased gait velocity 36.80 14.24 11 28478 139 29545899
Congestive hepatopathy 36.63 14.24 22 28467 1692 29544346
Application site discharge 36.45 14.24 11 28478 144 29545894
Neutropenia 36.40 14.24 44 28445 131667 29414371
Arthralgia 36.15 14.24 49 28440 139568 29406470
Housebound 36.03 14.24 12 28477 220 29545818
Haemoglobin decreased 35.85 14.24 31 28458 108344 29437694
Hallucination 35.35 14.24 109 28380 44603 29501435
Product dose omission issue 35.13 14.24 25 28464 96358 29449680
Prescription form tampering 35.03 14.24 14 28475 438 29545600
Spinal shock 34.93 14.24 8 28481 31 29546007
Injection site pruritus 34.58 14.24 35 28454 5814 29540224
Injection site swelling 34.57 14.24 44 28445 9373 29536665
Skin irritation 34.57 14.24 31 28458 4430 29541608
Glomerulonephritis acute 34.50 14.24 9 28480 66 29545972
Incorrect route of product administration 34.30 14.24 47 28442 10754 29535284
Cerebrovascular accident 33.63 14.24 16 28473 76895 29469143
Injection site inflammation 32.52 14.24 15 28474 670 29545368
Asthenia 32.48 14.24 103 28386 215147 29330891
Neuropathy peripheral 32.26 14.24 14 28475 71013 29475025
Acute kidney injury 32.14 14.24 139 28350 265128 29280910
Pleural effusion 31.37 14.24 15 28474 71893 29474145
Drug interaction 30.46 14.24 307 28182 197078 29348960
Feeding intolerance 30.46 14.24 9 28480 109 29545929
Disease progression 30.17 14.24 21 28468 81895 29464143
Bradyphrenia 30.14 14.24 28 28461 4186 29541852
Foetal distress syndrome 29.94 14.24 16 28473 983 29545055
Respiratory arrest 29.42 14.24 72 28417 25761 29520277
Epistaxis 29.10 14.24 7 28482 51697 29494341
Product administered at inappropriate site 29.01 14.24 19 28470 1701 29544337
Infusion related reaction 28.87 14.24 4 28485 43882 29502156
Breech presentation 28.63 14.24 9 28480 136 29545902
Interstitial lung disease 28.48 14.24 10 28479 57708 29488330
Vestibular ischaemia 28.47 14.24 6 28483 14 29546024
Malignant neoplasm progression 28.46 14.24 18 28471 73841 29472197
Sedation 28.33 14.24 56 28433 17349 29528689
Substance dependence 27.32 14.24 11 28478 351 29545687
Depressed level of consciousness 27.31 14.24 88 28401 36854 29509184
Troponin T increased 27.24 14.24 17 28472 1400 29544638
Substance use disorder 26.47 14.24 10 28479 268 29545770
Road traffic accident 26.46 14.24 51 28438 15510 29530528
Ear deformity acquired 26.27 14.24 5 28484 5 29546033
Death 26.05 14.24 468 28021 341616 29204422
Suicidal ideation 25.94 14.24 83 28406 34633 29511405
Application site scab 25.57 14.24 7 28482 63 29545975
Blood creatinine increased 25.05 14.24 27 28462 85075 29460963
Product use issue 24.98 14.24 107 28382 51337 29494701
Blood glucose increased 24.68 14.24 13 28476 58971 29487067
Drug effect less than expected 24.64 14.24 9 28480 219 29545819
Respiratory rate decreased 24.60 14.24 18 28471 1927 29544111
Dehydration 24.28 14.24 46 28443 114702 29431336
Injection site bruising 24.09 14.24 33 28456 7547 29538491
Product use in unapproved indication 24.01 14.24 29 28460 86846 29459192
Dependence 23.99 14.24 14 28475 1021 29545017
Thrombosis 23.89 14.24 6 28483 43039 29502999
Clumsiness 23.86 14.24 16 28473 1490 29544548
Joint swelling 23.81 14.24 9 28480 49621 29496417
Septic pulmonary embolism 23.79 14.24 4 28485 0 29546038
Aspartate aminotransferase increased 23.78 14.24 14 28475 59711 29486327
Vestibular disorder 23.75 14.24 14 28475 1040 29544998
Agitation neonatal 23.73 14.24 14 28475 1042 29544996
Haemorrhage 23.67 14.24 7 28482 45065 29500973
Therapy naive 23.62 14.24 5 28484 12 29546026
Hyperkalaemia 23.60 14.24 15 28474 61377 29484661
Product physical issue 23.46 14.24 18 28471 2070 29543968
Rash 23.23 14.24 99 28390 189720 29356318
Joint hyperextension 22.70 14.24 7 28482 99 29545939
Mastication disorder 22.51 14.24 14 28475 1146 29544892
Application site haemorrhage 22.04 14.24 10 28479 430 29545608
Back pain 21.64 14.24 41 28448 102243 29443795
Wrong dose 21.57 14.24 10 28479 452 29545586
Hyponatraemia 21.57 14.24 20 28469 67613 29478425
Chronic actinic dermatitis 21.51 14.24 5 28484 21 29546017
Thrombocytopenia 21.38 14.24 63 28426 134760 29411278
Coronary artery disease 21.22 14.24 8 28481 44182 29501856
Coordination abnormal 21.16 14.24 30 28459 7084 29538954
Altered state of consciousness 21.14 14.24 54 28435 19835 29526203
Accidental death 21.09 14.24 17 28472 2101 29543937
Compartment syndrome 20.92 14.24 18 28471 2434 29543604
Substance use 20.87 14.24 10 28479 487 29545551
Hypoxic-ischaemic encephalopathy 20.65 14.24 23 28466 4261 29541777
Neonatal aspiration 20.28 14.24 6 28483 73 29545965
Pulmonary congestion 20.22 14.24 40 28449 12396 29533642
COVID-19 20.02 14.24 5 28484 36009 29510029
International normalised ratio increased 19.74 14.24 9 28480 44363 29501675
Unresponsive to stimuli 19.61 14.24 61 28428 25065 29520973
Anxiety 19.54 14.24 145 28344 85220 29460818
Electrocardiogram T wave alternans 19.40 14.24 4 28485 8 29546030
Product substitution issue 19.33 14.24 33 28456 9139 29536899
Delirium 19.16 14.24 82 28407 39315 29506723
Herpes zoster 19.16 14.24 3 28486 30049 29515989
Treatment failure 18.92 14.24 6 28483 36933 29509105
Persecutory delusion 18.85 14.24 16 28473 2125 29543913
Product contamination 18.79 14.24 10 28479 609 29545429
Micrognathia 18.65 14.24 8 28481 300 29545738
Myocardial infarction 18.62 14.24 50 28439 110246 29435792
Laryngomalacia 18.53 14.24 8 28481 305 29545733
Brief psychotic disorder with marked stressors 18.45 14.24 7 28482 190 29545848
Emotional poverty 18.38 14.24 9 28480 460 29545578
Renal failure 18.38 14.24 56 28433 118543 29427495
Poisoning deliberate 18.29 14.24 25 28464 5706 29540332
Embolia cutis medicamentosa 18.24 14.24 7 28482 196 29545842
Pancytopenia 17.89 14.24 33 28456 83135 29462903
Application site odour 17.84 14.24 3 28486 0 29546038
Injection site ischaemia 17.84 14.24 3 28486 0 29546038
Gastrointestinal haemorrhage 17.60 14.24 31 28458 79502 29466536
Alcohol interaction 17.50 14.24 17 28472 2686 29543352
Application site ulcer 17.36 14.24 4 28485 16 29546022
Product colour issue 17.18 14.24 8 28481 365 29545673
Victim of crime 17.18 14.24 8 28481 365 29545673
Mydriasis 17.13 14.24 25 28464 6060 29539978
Rectal haemorrhage 17.02 14.24 6 28483 34543 29511495
Behavioural addiction 16.98 14.24 4 28485 18 29546020
Deafness bilateral 16.84 14.24 11 28478 980 29545058
Cyanosis 16.84 14.24 35 28454 11232 29534806
Accidental exposure to product 16.78 14.24 34 28455 10719 29535319
Product physical consistency issue 16.73 14.24 8 28481 388 29545650
Disturbance in attention 16.71 14.24 52 28437 21372 29524666
Multiple cardiac defects 16.67 14.24 5 28484 64 29545974
Blood bilirubin increased 16.50 14.24 6 28483 33887 29512151
Psychotic disorder 16.43 14.24 50 28439 20304 29525734
Incoherent 16.43 14.24 20 28469 4072 29541966
Respiratory failure 16.41 14.24 44 28445 97087 29448951
Diabetes mellitus 16.33 14.24 9 28480 39822 29506216
Neutrophil count decreased 16.26 14.24 11 28478 43556 29502482
Infection 16.02 14.24 31 28458 76720 29469318
Eschar 15.99 14.24 9 28480 613 29545425
Weight increased 15.97 14.24 31 28458 76636 29469402
Gun shot wound 15.94 14.24 11 28478 1074 29544964
Dermal absorption impaired 15.76 14.24 3 28486 3 29546035
Administration site abscess sterile 15.76 14.24 3 28486 3 29546035
Acute cardiac event 15.75 14.24 4 28485 26 29546012
Bronchitis 15.60 14.24 8 28481 36860 29509178
Injection site scab 15.49 14.24 4 28485 28 29546010
Infantile vomiting 15.25 14.24 4 28485 30 29546008
Tachyphrenia 15.20 14.24 11 28478 1158 29544880
Psoriasis 15.19 14.24 6 28483 32221 29513817
Hallucinations, mixed 15.19 14.24 15 28474 2418 29543620
Hyperglycaemia 15.18 14.24 7 28482 34280 29511758
Pain in extremity 15.14 14.24 55 28434 110378 29435660
Anaphylactic reaction 15.00 14.24 4 28485 27569 29518469
Hypoventilation 14.99 14.24 16 28473 2825 29543213
Neuromuscular blockade 14.80 14.24 6 28483 195 29545843
Nasal septum deviation 14.74 14.24 10 28479 949 29545089
Neonatal respiratory distress 14.70 14.24 8 28481 510 29545528
Chronic hepatitis C 14.67 14.24 7 28482 338 29545700
Off label use 14.66 14.24 203 28286 300597 29245441
Acute myocardial infarction 14.66 14.24 15 28474 48423 29497615
Injection site induration 14.47 14.24 15 28474 2561 29543477

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 1620.19 12.68 1041 42256 131333 64324102
Drug withdrawal syndrome 1429.47 12.68 598 42699 30693 64424742
Application site pruritus 1121.12 12.68 293 43004 3246 64452189
Drug dependence 1001.32 12.68 475 42822 32837 64422598
Product adhesion issue 967.35 12.68 242 43055 2217 64453218
Application site erythema 816.99 12.68 243 43054 4446 64450989
Intentional product misuse 668.35 12.68 479 42818 71816 64383619
Application site rash 600.62 12.68 158 43139 1796 64453639
Substance abuse 552.85 12.68 215 43082 9077 64446358
Miosis 524.05 12.68 229 43068 13037 64442398
Toxicity to various agents 484.57 12.68 870 42427 362643 64092792
Application site pain 483.48 12.68 159 43138 4089 64451346
Application site burn 476.67 12.68 110 43187 686 64454749
Inadequate analgesia 457.18 12.68 150 43147 3828 64451607
Application site vesicles 450.31 12.68 116 43181 1206 64454229
Alcohol abuse 298.27 12.68 115 43182 4737 64450698
Respiratory depression 286.97 12.68 185 43112 23258 64432177
Overdose 280.18 12.68 433 42864 159133 64296302
Withdrawal syndrome 269.49 12.68 178 43119 23314 64432121
Drug use disorder 257.01 12.68 110 43187 5944 64449491
Coma 222.58 12.68 284 43013 87331 64368104
Intentional product use issue 220.35 12.68 295 43002 95069 64360366
Somnolence 200.47 12.68 430 42867 203215 64252220
Application site irritation 195.57 12.68 63 43234 1513 64453922
Application site scar 178.03 12.68 38 43259 155 64455280
Accidental overdose 176.42 12.68 160 43137 33397 64422038
Application site dryness 168.44 12.68 36 43261 148 64455287
Accidental exposure to product by child 153.09 12.68 59 43238 2426 64453009
Application site discolouration 141.57 12.68 41 43256 679 64454756
Drug screen positive 139.91 12.68 71 43226 5658 64449777
Application site discharge 134.83 12.68 33 43264 273 64455162
Wrong technique in product usage process 130.53 12.68 188 43109 64786 64390649
Application site exfoliation 127.27 12.68 32 43265 299 64455136
Application site urticaria 116.36 12.68 28 43269 214 64455221
Application site erosion 108.02 12.68 26 43271 199 64455236
Injection site abscess 107.31 12.68 39 43258 1359 64454076
Agitation 101.41 12.68 199 43098 88168 64367267
Asphyxia 101.30 12.68 69 43228 9497 64445938
Injection site ulcer 96.60 12.68 30 43267 637 64454798
Drug detoxification 94.91 12.68 24 43273 230 64455205
Hyperhidrosis 93.36 12.68 237 43060 124683 64330752
Injection site pain 91.33 12.68 219 43078 111189 64344246
Aggression 88.80 12.68 131 43166 46101 64409334
Injection site infection 86.18 12.68 36 43261 1829 64453606
Brachial artery entrapment syndrome 81.99 12.68 13 43284 0 64455435
Pyrexia 80.99 12.68 158 43139 558486 63896949
Logorrhoea 78.37 12.68 43 43254 4016 64451419
Inappropriate schedule of product administration 77.34 12.68 183 43114 92103 64363332
Accidental poisoning 77.21 12.68 31 43266 1422 64454013
Application site swelling 76.95 12.68 25 43272 617 64454818
Brain oedema 76.61 12.68 84 43213 21991 64433444
Bradypnoea 73.89 12.68 45 43252 5114 64450321
Maternal exposure during pregnancy 73.80 12.68 184 43113 95700 64359735
Product physical issue 73.47 12.68 39 43258 3410 64452025
Febrile neutropenia 73.08 12.68 18 43279 187639 64267796
Endocarditis staphylococcal 72.88 12.68 24 43273 619 64454816
Death 72.72 12.68 563 42734 482142 63973293
Application site reaction 70.38 12.68 24 43273 691 64454744
Drug delivery system removal 69.38 12.68 11 43286 0 64455435
Hallucination 67.23 12.68 150 43147 72638 64382797
Drug diversion 66.53 12.68 26 43271 1110 64454325
Drug withdrawal syndrome neonatal 66.18 12.68 18 43279 234 64455201
Euphoric mood 66.15 12.68 46 43251 6545 64448890
Infusion related reaction 65.57 12.68 15 43282 164452 64290983
Hepatitis C 64.80 12.68 56 43241 10959 64444476
Application site scab 64.70 12.68 17 43280 192 64455243
Diarrhoea 62.93 12.68 261 43036 722443 63732992
Disturbance in attention 60.38 12.68 103 43194 40971 64414464
Product administered at inappropriate site 60.19 12.68 33 43264 3077 64452358
Arthropathy 59.64 12.68 6 43291 120961 64334474
Cluster headache 58.85 12.68 22 43275 831 64454604
Intentional underdose 57.64 12.68 28 43269 2030 64453405
Application site haemorrhage 57.44 12.68 24 43273 1220 64454215
Respiratory arrest 56.77 12.68 116 43181 52869 64402566
Disorientation 56.05 12.68 119 43178 55709 64399726
Product solubility abnormal 55.56 12.68 21 43276 818 64454617
Depressed level of consciousness 55.17 12.68 149 43148 81287 64374148
Hyperaesthesia 55.08 12.68 49 43248 9965 64445470
Drug interaction 54.25 12.68 422 42875 361661 64093774
Application site ulcer 53.17 12.68 13 43284 107 64455328
Skin irritation 52.59 12.68 46 43251 9148 64446287
Drug abuser 52.44 12.68 38 43259 5770 64449665
Cough 52.41 12.68 76 43221 302072 64153363
Suicidal ideation 51.50 12.68 128 43169 66414 64389021
Pulmonary oedema 51.35 12.68 142 43155 78532 64376903
Synovitis 51.32 12.68 4 43293 99086 64356349
Arthralgia 51.18 12.68 141 43156 442119 64013316
Joint swelling 50.79 12.68 42 43255 215340 64240095
Sarcopenia 50.60 12.68 16 43281 361 64455074
Intentional removal of drug delivery system by patient 50.46 12.68 8 43289 0 64455435
Substance dependence 50.40 12.68 17 43280 473 64454962
Stress cardiomyopathy 50.32 12.68 45 43252 9212 64446223
Dysarthria 49.96 12.68 118 43179 59288 64396147
Fatigue 49.86 12.68 297 43000 748433 63707002
Injection site necrosis 49.48 12.68 22 43275 1303 64454132
Therapeutic product effect increased 49.24 12.68 22 43275 1318 64454117
Dermo-hypodermitis 48.75 12.68 17 43280 524 64454911
Platelet count decreased 48.56 12.68 26 43271 167685 64287750
Poisoning 47.90 12.68 66 43231 21813 64433622
Taste disorder 47.64 12.68 44 43253 9389 64446046
Blepharospasm 47.21 12.68 29 43268 3346 64452089
Drug screen negative 46.44 12.68 14 43283 268 64455167
White blood cell count decreased 46.39 12.68 24 43273 157813 64297622
Sinusitis 46.25 12.68 20 43277 145908 64309527
Restlessness 46.09 12.68 90 43207 39695 64415740
Unresponsive to stimuli 45.57 12.68 103 43194 50290 64405145
Application site odour 44.56 12.68 9 43288 26 64455409
Pneumonia 44.43 12.68 209 43088 559367 63896068
Neutropenia 43.82 12.68 58 43239 239566 64215869
Injection site extravasation 43.35 12.68 39 43258 8047 64447388
Injection site erosion 42.99 12.68 11 43286 111 64455324
Endocarditis 42.13 12.68 41 43256 9337 64446098
Treatment failure 42.10 12.68 13 43284 116803 64338632
Incorrect route of product administration 41.85 12.68 64 43233 23234 64432201
Product physical consistency issue 41.70 12.68 15 43282 507 64454928
Product dose omission issue 40.01 12.68 43 43254 194704 64260731
Impaired reasoning 39.81 12.68 10 43287 93 64455342
Decreased gait velocity 39.76 12.68 11 43286 153 64455282
Application site inflammation 39.59 12.68 14 43283 450 64454985
Bradycardia foetal 39.25 12.68 10 43287 99 64455336
Haemoglobin decreased 39.05 12.68 44 43253 195019 64260416
Impaired driving ability 38.75 12.68 29 43268 4625 64450810
Subchondral insufficiency fracture 38.74 12.68 9 43288 58 64455377
Yawning 38.50 12.68 18 43279 1198 64454237
Application site dermatitis 38.45 12.68 11 43286 174 64455261
17 ketosteroids urine abnormal 37.84 12.68 6 43291 0 64455435
Infection 37.78 12.68 41 43256 184839 64270596
Congenital multiplex arthrogryposis 37.55 12.68 7 43290 11 64455424
Deafness neurosensory 36.67 12.68 32 43265 6342 64449093
Delirium 36.67 12.68 116 43181 69078 64386357
Exposure during pregnancy 35.62 12.68 124 43173 77551 64377884
Systemic lupus erythematosus 35.41 12.68 5 43292 77607 64377828
Breakthrough pain 35.38 12.68 17 43280 1203 64454232
Rheumatoid arthritis 35.18 12.68 35 43262 164259 64291176
Confusional state 35.06 12.68 297 43000 260847 64194588
Bradyphrenia 34.75 12.68 37 43260 9369 64446066
Aptyalism 33.63 12.68 14 43283 705 64454730
Anaemia 33.30 12.68 136 43161 378544 64076891
Interstitial lung disease 33.25 12.68 12 43285 97720 64357715
Application site pustules 32.71 12.68 7 43290 29 64455406
Product substitution issue 31.99 12.68 49 43248 17812 64437623
Injection site cellulitis 31.84 12.68 17 43280 1504 64453931
Poisoning deliberate 31.59 12.68 42 43255 13416 64442019
Altered state of consciousness 31.55 12.68 75 43222 37827 64417608
Vestibular ischaemia 30.63 12.68 6 43291 14 64455421
Product dispensing issue 30.55 12.68 8 43289 89 64455346
Dyspnoea 30.55 12.68 322 42975 718352 63737083
Glomerulonephritis acute 30.32 12.68 9 43288 163 64455272
Application site hypersensitivity 29.65 12.68 10 43287 278 64455157
Injection site discharge 29.11 12.68 11 43286 428 64455007
Hypertension 28.94 12.68 84 43213 259177 64196258
Cerebrovascular accident 28.67 12.68 30 43267 137553 64317882
Mucosal inflammation 28.62 12.68 4 43293 62580 64392855
Housebound 28.50 12.68 11 43286 454 64454981
Herpes zoster 28.20 12.68 9 43288 79178 64376257
Ear deformity acquired 28.07 12.68 5 43292 5 64455430
Nasopharyngitis 27.83 12.68 56 43241 196017 64259418
Cardiac failure congestive 27.74 12.68 28 43269 130552 64324883
Weight increased 27.74 12.68 64 43233 213284 64242151
Glossodynia 27.64 12.68 5 43292 64691 64390744
Alopecia 27.41 12.68 43 43254 165647 64289788
Dermatitis contact 27.40 12.68 32 43265 8968 64446467
Congestive hepatopathy 27.09 12.68 22 43275 3951 64451484
Swelling 27.06 12.68 41 43256 160177 64295258
Faecaloma 27 12.68 33 43264 9695 64445740
Thrombocytopenia 26.85 12.68 70 43227 223731 64231704
Off label use 26.68 12.68 284 43013 632522 63822913
Product packaging quantity issue 26.63 12.68 13 43284 953 64454482
Sedation 26.22 12.68 74 43223 41388 64414047
Accidental death 26.19 12.68 21 43276 3704 64451731
Eyelid retraction 26.19 12.68 6 43291 36 64455399
Feeling drunk 26.17 12.68 22 43275 4145 64451290
Psychomotor skills impaired 25.61 12.68 21 43276 3824 64451611
Defaecation disorder 25.02 12.68 10 43287 453 64454982
Troponin T increased 24.98 12.68 17 43280 2336 64453099
Rash 24.88 12.68 193 43104 458356 63997079
Micrognathia 24.87 12.68 5 43292 14 64455421
Gastrointestinal disorder 24.40 12.68 15 43282 89694 64365741
Disease progression 24.17 12.68 36 43261 141644 64313791
Paranoia 24.02 12.68 41 43256 16311 64439124
Aspartate aminotransferase increased 23.98 12.68 27 43270 119761 64335674
Application site papules 23.97 12.68 6 43291 55 64455380
Substance use disorder 23.63 12.68 9 43288 358 64455077
Tachyphrenia 23.42 12.68 15 43282 1861 64453574
Atrial fibrillation 23.32 12.68 50 43247 171039 64284396
Chronic actinic dermatitis 23.31 12.68 5 43292 21 64455414
Asthenia 23.29 12.68 180 43117 427864 64027571
Application site induration 22.99 12.68 4 43293 3 64455432
Congenital coronary artery malformation 22.98 12.68 6 43291 66 64455369
Pain in extremity 22.94 12.68 115 43182 302970 64152465
Product preparation error 22.83 12.68 20 43277 3985 64451450
Vulvar basal cell carcinoma 22.59 12.68 5 43292 25 64455410
Suicide attempt 22.54 12.68 101 43196 70906 64384529
Maternal use of illicit drugs 21.57 12.68 4 43293 6 64455429
Premature delivery 21.46 12.68 42 43255 18547 64436888
Abnormal behaviour 21.25 12.68 60 43237 33562 64421873
Prescription drug used without a prescription 21.20 12.68 16 43281 2584 64452851
Hallucination, visual 20.96 12.68 53 43244 27781 64427654
Emotional poverty 20.93 12.68 10 43287 699 64454736
Therapy non-responder 20.92 12.68 9 43288 65890 64389545
Foetal exposure during pregnancy 20.92 12.68 20 43277 4456 64450979
Contraindicated product administered 20.83 12.68 25 43272 107804 64347631
Cyanosis 20.82 12.68 46 43251 22109 64433326
Therapy naive 20.80 12.68 5 43292 38 64455397
Mydriasis 20.68 12.68 37 43260 15275 64440160
Substance abuser 20.41 12.68 6 43291 105 64455330
Injection site inflammation 20.22 12.68 17 43280 3204 64452231
Bronchitis 20.18 12.68 26 43271 108717 64346718
Vomiting 20.16 12.68 498 42799 550619 63904816
Neuropathy peripheral 19.91 12.68 30 43267 117495 64337940
Pleural effusion 19.85 12.68 34 43263 126525 64328910
Cataract 19.78 12.68 5 43292 51257 64404178
Blood glucose increased 19.74 12.68 22 43275 98051 64357384
Coronary artery disease 19.59 12.68 8 43289 60425 64395010
Neurosis 19.58 12.68 8 43289 384 64455051
Hypersensitivity 19.55 12.68 67 43230 196385 64259050
Neutrophil count decreased 19.52 12.68 14 43283 77182 64378253
Lack of application site rotation 19.45 12.68 4 43293 13 64455422
Epilepsy 19.42 12.68 58 43239 33473 64421962
Hypoventilation 19.37 12.68 22 43275 5984 64449451
Application site bruise 19.31 12.68 7 43290 242 64455193
Victim of sexual abuse 19.29 12.68 8 43289 399 64455036
Nasal congestion 19.17 12.68 8 43289 59650 64395785
Abortion spontaneous 19.06 12.68 48 43249 25095 64430340
Respiratory rate decreased 19.00 12.68 19 43278 4472 64450963
Foetal non-stress test abnormal 18.92 12.68 3 43294 0 64455435
Substance use 18.81 12.68 9 43288 631 64454804
Brief psychotic disorder with marked stressors 18.73 12.68 7 43290 264 64455171
Vestibular disorder 18.45 12.68 14 43283 2279 64453156
Injection site erythema 18.35 12.68 95 43202 70705 64384730
Venous thrombosis 18.29 12.68 22 43275 6359 64449076
Radial nerve palsy 18.28 12.68 8 43289 456 64454979
Injection site ischaemia 18.24 12.68 4 43293 19 64455416
Cryoglobulinaemia 18.17 12.68 9 43288 681 64454754
Haematocrit decreased 18.10 12.68 7 43290 54648 64400787
Haemorrhage 18.04 12.68 16 43281 79335 64376100
Mastication disorder 17.99 12.68 14 43283 2365 64453070
Incoherent 17.93 12.68 23 43274 7095 64448340
Allodynia 17.88 12.68 11 43286 1272 64454163
Pancytopenia 17.81 12.68 44 43253 143265 64312170
Hepatic enzyme increased 17.68 12.68 38 43259 129905 64325530
Epistaxis 17.66 12.68 24 43273 98107 64357328
Abdominal discomfort 17.59 12.68 63 43234 182259 64273176
Intervertebral discitis 17.58 12.68 17 43280 3840 64451595
Pulmonary congestion 17.49 12.68 45 43252 23835 64431600
Persistent depressive disorder 17.45 12.68 10 43287 1016 64454419
Influenza 17.28 12.68 28 43269 106503 64348932
Blood cholesterol increased 17.28 12.68 6 43291 50060 64405375
Application site infection 17.25 12.68 5 43292 83 64455352
Hypotension 17.24 12.68 168 43129 380806 64074629
Chronic hepatitis C 17.07 12.68 8 43289 535 64454900
Judgement impaired 17.03 12.68 10 43287 1063 64454372
Reaction to excipient 16.98 12.68 11 43286 1392 64454043
Administration site abscess sterile 16.84 12.68 3 43294 3 64455432
Hypertonia 16.82 12.68 21 43276 6304 64449131
Accidental exposure to product 16.61 12.68 47 43250 26317 64429118
Chest discomfort 16.60 12.68 33 43264 116073 64339362
Tooth hypoplasia 16.46 12.68 6 43291 211 64455224
Product odour abnormal 16.36 12.68 10 43287 1143 64454292
COVID-19 16.22 12.68 12 43285 65128 64390307
Malignant neoplasm progression 16.21 12.68 32 43265 112839 64342596
Upper respiratory tract infection 16.16 12.68 15 43282 72770 64382665
Constipation 15.95 12.68 229 43068 229108 64226327
Hallucinations, mixed 15.94 12.68 20 43277 6032 64449403
Blood creatinine increased 15.87 12.68 43 43254 135739 64319696
Alcohol interaction 15.71 12.68 17 43280 4384 64451051
Lactic acidosis 15.70 12.68 11 43286 61399 64394036
Wrong dose 15.69 12.68 10 43287 1231 64454204
Psoriasis 15.66 12.68 15 43282 71688 64383747
Victim of crime 15.66 12.68 7 43290 420 64455015
Cystic lymphangioma 15.63 12.68 3 43294 6 64455429
Genitourinary symptom 15.44 12.68 6 43291 252 64455183
Musculoskeletal stiffness 15.18 12.68 38 43259 123168 64332267
Oral administration complication 15.14 12.68 5 43292 130 64455305
Urinary incontinence 15.11 12.68 56 43241 36095 64419340
Hyperkalaemia 15.11 12.68 28 43269 101101 64354334
Dementia with Lewy bodies 15.07 12.68 8 43289 699 64454736
Clostridium difficile infection 15.01 12.68 3 43294 36160 64419275
Pneumonia aspiration 14.99 12.68 79 43218 59192 64396243
Road traffic accident 14.89 12.68 50 43247 30695 64424740
Dependence 14.84 12.68 12 43285 2143 64453292
Urticaria 14.82 12.68 50 43247 147267 64308168
Persecutory delusion 14.73 12.68 16 43281 4142 64451293
Testicular pain 14.73 12.68 11 43286 1749 64453686
Bruxism 14.72 12.68 15 43282 3609 64451826
Embolia cutis medicamentosa 14.67 12.68 7 43290 488 64454947
Repetitive strain injury 14.59 12.68 5 43292 146 64455289
Electrocardiogram T wave alternans 14.57 12.68 4 43293 54 64455381
Echocardiogram abnormal 14.57 12.68 11 43286 1778 64453657
Product contamination 14.48 12.68 9 43288 1060 64454375
Diabetes mellitus 14.41 12.68 14 43283 66460 64388975
Injection site oedema 14.40 12.68 9 43288 1071 64454364
Dyspnoea exertional 14.34 12.68 17 43280 73713 64381722
Myocardial infarction 14.26 12.68 60 43237 165761 64289674
Injection site irritation 14.25 12.68 14 43283 3226 64452209
Ankyloglossia congenital 14.10 12.68 3 43294 12 64455423
Adjacent segment degeneration 14.10 12.68 3 43294 12 64455423
Reversible cerebral vasoconstriction syndrome 13.96 12.68 12 43285 2330 64453105
Developmental hip dysplasia 13.96 12.68 5 43292 167 64455268
Anxiety 13.95 12.68 202 43095 202447 64252988
Sepsis 13.88 12.68 94 43203 230247 64225188
Discoloured vomit 13.83 12.68 9 43288 1148 64454287
Oropharyngeal pain 13.82 12.68 24 43273 88843 64366592
Type 2 diabetes mellitus 13.75 12.68 3 43294 34017 64421418
Dermal absorption impaired 13.73 12.68 3 43294 14 64455421
Placental disorder 13.52 12.68 8 43289 862 64454573
Cachexia 13.39 12.68 23 43274 9194 64446241
Maternal drugs affecting foetus 13.28 12.68 10 43287 1610 64453825
Delusion 13.25 12.68 34 43263 17980 64437455
Tricuspid valve replacement 13.24 12.68 3 43294 17 64455418
Lividity 13.14 12.68 6 43291 378 64455057
Mental status changes 13.12 12.68 13 43284 61149 64394286
Productive cough 13.07 12.68 18 43279 73185 64382250
Pericardial effusion 13.05 12.68 5 43292 39249 64416186
Product colour issue 13.04 12.68 7 43290 626 64454809
Throat irritation 12.99 12.68 3 43294 32708 64422727
Cardiogenic shock 12.83 12.68 3 43294 32424 64423011
Blood pressure decreased 12.76 12.68 24 43273 86175 64369260
Injection site vesicles 12.73 12.68 12 43285 2628 64452807

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 59.05 31.76 43 160 2010 82465
Poor feeding infant 39.95 31.76 13 190 84 84391

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 (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




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Postoperative pain associated with surgical procedures Indication

🐶 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 INC 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 INC 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 INC 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 INC 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
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 TREATEMENT 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 TREATEMENT 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 TREATEMENT 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 TREATEMENT 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 TREATEMENT 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 TREATEMENT 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 TREATEMENT 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 INC N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 12MG BASE;EQ 3MG BASE SUBOXONE INDIVIOR INC 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 INC 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 INC 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 INC N022410 Aug. 10, 2012 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 4MG BASE;EQ 1MG BASE SUBOXONE INDIVIOR INC 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 INC N022410 Aug. 30, 2010 RX FILM BUCCAL, SUBLINGUAL 11135216 Aug. 7, 2029 TREATING OPIOID USE DISORDER
EQ 8MG BASE;EQ 2MG BASE SUBOXONE INDIVIOR INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC 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 INC N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 8921387 Jan. 6, 2032 TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
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 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 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 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 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 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 INC N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR INC N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS 11000520 Nov. 6, 2035 TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR INC 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)

None

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
001573 NDDF
004632 NDDF
21066009 SNOMEDCT_US
31684002 SNOMEDCT_US
387173000 SNOMEDCT_US
4018880 VANDF
4019644 VANDF

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 0054-0177 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 0054-0189 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 0093-3656 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 0093-3658 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 Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 16 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3153 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3153 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 8 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3156 TABLET 2 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3156 TABLET 2 mg SUBLINGUAL ANDA 32 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8765 FILM 2 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8766 FILM 4 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8767 FILM 8 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8768 FILM 12 mg SUBLINGUAL ANDA 34 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8005 TABLET 2 mg SUBLINGUAL ANDA 37 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8020 TABLET 8 mg SUBLINGUAL ANDA 37 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2012 INJECTION, SOLUTION 0.30 mg INTRAMUSCULAR ANDA 31 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-0725 INJECTION, SOLUTION 0.32 mg INTRAMUSCULAR ANDA 21 sections