buprenorphine 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
Drug withdrawal syndrome 1753.35 13.47 686 38055 27336 53282989
Application site pruritus 1580.09 13.47 404 38337 3745 53306580
Product adhesion issue 1513.80 13.47 414 38327 5083 53305242
Application site erythema 1099.06 13.47 317 38424 4774 53305551
Drug dependence 882.96 13.47 390 38351 21082 53289243
Application site rash 849.82 13.47 226 38515 2470 53307855
Inadequate analgesia 672.83 13.47 191 38550 2704 53307621
Application site vesicles 665.47 13.47 165 38576 1329 53308996
Application site pain 653.59 13.47 203 38538 3980 53306345
Drug abuse 601.71 13.47 446 38295 65080 53245245
Application site burn 523.43 13.47 123 38618 767 53309558
Drug withdrawal syndrome neonatal 455.50 13.47 132 38609 2018 53308307
Maternal exposure during pregnancy 446.99 13.47 557 38184 155082 53155243
Wrong technique in product usage process 390.78 13.47 334 38407 59698 53250627
Product solubility abnormal 348.71 13.47 89 38652 815 53309510
Application site irritation 331.72 13.47 100 38641 1764 53308561
Withdrawal syndrome 311.90 13.47 187 38554 19114 53291211
Intentional underdose 292.55 13.47 92 38649 1879 53308446
Substance abuse 283.88 13.47 111 38630 4383 53305942
Product preparation error 229.02 13.47 95 38646 4380 53305945
Foetal exposure during pregnancy 227.46 13.47 194 38547 34521 53275804
Application site scar 219.17 13.47 48 38693 206 53310119
Drug screen negative 218.59 13.47 52 38689 344 53309981
Application site discharge 215.48 13.47 44 38697 123 53310202
Exposure during pregnancy 198.21 13.47 338 38403 124522 53185803
Application site erosion 194.95 13.47 42 38699 164 53310161
Inappropriate schedule of product administration 192.42 13.47 254 38487 74624 53235701
Application site exfoliation 173.63 13.47 42 38699 301 53310024
Application site dryness 173.08 13.47 37 38704 138 53310187
Product substitution issue 172.87 13.47 120 38621 15746 53294579
Premature delivery 161.08 13.47 141 38600 25963 53284362
Product dosage form issue 159.08 13.47 31 38710 62 53310263
Application site discolouration 154.98 13.47 46 38695 767 53309558
Oral administration complication 153.96 13.47 33 38708 125 53310200
Product use issue 151.02 13.47 321 38420 139263 53171062
Abortion spontaneous 133.56 13.47 167 38574 46468 53263857
Hyperhidrosis 132.86 13.47 246 38495 96547 53213778
Nausea 131.67 13.47 967 37774 755124 52555201
Drug use disorder 130.64 13.47 58 38683 3161 53307164
Euphoric mood 129.31 13.47 64 38677 4465 53305860
Application site urticaria 128.87 13.47 32 38709 259 53310066
Product physical issue 128.77 13.47 67 38674 5195 53305130
Oral mucosal blistering 125.55 13.47 66 38675 5227 53305098
Intentional product misuse 121.37 13.47 164 38577 49228 53261097
Rheumatoid arthritis 115.73 13.47 42 38699 314489 52995836
Overdose 112.13 13.47 244 38497 107492 53202833
Drug screen positive 108.43 13.47 54 38687 3818 53306507
Respiratory depression 108.05 13.47 83 38658 12723 53297602
Application site swelling 107.34 13.47 32 38709 542 53309783
Application site reaction 105.93 13.47 34 38707 743 53309582
Vomiting 102.83 13.47 664 38077 496475 52813850
Product packaging quantity issue 100.00 13.47 37 38704 1252 53309073
Toxicity to various agents 98.09 13.47 366 38375 219232 53091093
Accidental exposure to product by child 91.24 13.47 34 38707 1174 53309151
Product administered at inappropriate site 89.86 13.47 42 38699 2580 53307745
Placental hypertrophy 87.20 13.47 14 38727 0 53310325
Placental disorder 86.86 13.47 35 38706 1496 53308829
Maternal exposure during breast feeding 85.02 13.47 44 38697 3373 53306952
Somnolence 84.61 13.47 291 38450 167443 53142882
Product physical consistency issue 80.30 13.47 25 38716 493 53309832
Jaundice neonatal 80.30 13.47 29 38712 915 53309410
Tongue blistering 79.72 13.47 33 38708 1512 53308813
Therapeutic product effect increased 77.96 13.47 30 38711 1133 53309192
Drug diversion 74.76 13.47 27 38714 852 53309473
Yawning 73.90 13.47 28 38713 1013 53309312
Drug detoxification 72.74 13.47 19 38722 192 53310133
Pyrexia 70.73 13.47 115 38626 403078 52907247
Drug delivery system removal 68.51 13.47 11 38730 0 53310325
Exposure via breast milk 66.00 13.47 29 38712 1541 53308784
Cough 65.83 13.47 54 38687 256839 53053486
Sinusitis 64.52 13.47 21 38720 168543 53141782
Fatigue 64.29 13.47 293 38448 730213 52580112
Infusion related reaction 64.13 13.47 17 38724 155940 53154385
Abortion induced 63.81 13.47 57 38684 10769 53299556
Nasopharyngitis 62.14 13.47 31 38710 192264 53118061
Alcohol abuse 61.41 13.47 30 38711 2034 53308291
Systemic lupus erythematosus 61.33 13.47 9 38732 125405 53184920
Application site ulcer 60.78 13.47 15 38726 118 53310207
Application site scab 59.70 13.47 16 38725 180 53310145
Joint swelling 55.68 13.47 53 38688 234585 53075740
Rhesus incompatibility 54.77 13.47 13 38728 85 53310240
Diarrhoea 54.30 13.47 252 38489 625294 52685031
Application site dermatitis 53.23 13.47 15 38726 206 53310119
Neutropenia 52.42 13.47 25 38716 159160 53151165
Breakthrough pain 52.35 13.47 23 38718 1222 53309103
Selective abortion 52.04 13.47 14 38727 160 53310165
Contraindicated product administered 51.71 13.47 17 38724 135612 53174713
Hyperaesthesia 51.71 13.47 46 38695 8643 53301682
Injection site infection 51.27 13.47 25 38716 1688 53308637
Injection site pain 50.52 13.47 189 38552 113202 53197123
Hallucination 50.42 13.47 117 38624 53721 53256604
Application site haemorrhage 50.18 13.47 21 38720 989 53309336
Alopecia 50.02 13.47 58 38683 234525 53075800
Injection site extravasation 49.01 13.47 42 38699 7510 53302815
Arthropathy 48.47 13.47 21 38720 141432 53168893
Stress cardiomyopathy 48.34 13.47 44 38697 8518 53301807
Product dispensing issue 48.01 13.47 12 38729 100 53310225
Arthralgia 47.73 13.47 162 38579 439621 52870704
Product formulation issue 47.17 13.47 18 38723 664 53309661
Platelet count decreased 45.94 13.47 11 38730 108088 53202237
Miosis 45.56 13.47 39 38702 6963 53303362
Haemoglobin decreased 44.54 13.47 22 38719 137285 53173040
Treatment failure 44.09 13.47 19 38722 128384 53181941
Febrile neutropenia 43.97 13.47 11 38730 104925 53205400
Pneumonia 43.48 13.47 151 38590 407018 52903307
Thrombocytopenia 42.39 13.47 24 38717 138703 53171622
Respiratory arrest 41.94 13.47 82 38659 33458 53276867
Prescription drug used without a prescription 41.49 13.47 22 38719 1772 53308553
Disturbance in attention 40.52 13.47 82 38659 34301 53276024
Device leakage 39.83 13.47 34 38707 6046 53304279
Suicidal ideation 39.65 13.47 115 38626 60396 53249929
Foetal growth restriction 38.81 13.47 36 38705 7138 53303187
Infection 38.42 13.47 41 38700 172164 53138161
Subchondral insufficiency fracture 38.30 13.47 9 38732 56 53310269
Faecaloma 38.24 13.47 38 38703 8203 53302122
Poor feeding infant 37.70 13.47 12 38729 255 53310070
17 ketosteroids urine abnormal 37.37 13.47 6 38735 0 53310325
White blood cell count decreased 37.36 13.47 22 38719 124453 53185872
Impaired reasoning 37.26 13.47 9 38732 64 53310261
Bradycardia foetal 36.80 13.47 13 38728 384 53309941
Injection site cellulitis 36.78 13.47 18 38723 1225 53309100
Application site odour 36.40 13.47 8 38733 35 53310290
Anaemia 35.68 13.47 94 38647 276624 53033701
Application site induration 34.94 13.47 6 38735 3 53310322
Low birth weight baby 34.67 13.47 32 38709 6305 53304020
Hepatic enzyme increased 32.94 13.47 26 38715 126169 53184156
Application site inflammation 32.89 13.47 12 38729 390 53309935
Migraine 32.50 13.47 130 38611 80287 53230038
Anxiety 32.36 13.47 249 38492 196455 53113870
Dermatitis contact 32.13 13.47 36 38705 8916 53301409
Therapy naive 31.78 13.47 7 38734 31 53310294
Feeling abnormal 29.79 13.47 184 38557 135117 53175208
Victim of sexual abuse 29.43 13.47 12 38729 529 53309796
Premature baby 29.24 13.47 52 38689 19749 53290576
Extra dose administered 29.15 13.47 27 38714 5343 53304982
Asthenia 28.77 13.47 140 38601 343450 52966875
Product colour issue 28.74 13.47 13 38728 740 53309585
Intentional product use issue 28.34 13.47 116 38625 72378 53237947
Psoriasis 28.16 13.47 14 38727 87075 53223250
Application site bruise 28.10 13.47 10 38731 302 53310023
Non-cardiogenic pulmonary oedema 27.83 13.47 12 38729 609 53309716
Incorrect route of product administration 27.73 13.47 50 38691 19194 53291131
Tongue discomfort 27.60 13.47 18 38723 2128 53308197
Application site papules 27.53 13.47 7 38734 63 53310262
Restlessness 27.35 13.47 62 38679 28025 53282300
Piloerection 27.20 13.47 10 38731 332 53309993
Injection site abscess 27.12 13.47 14 38727 1067 53309258
Foreign body reaction 27.05 13.47 7 38734 68 53310257
Hypertension 26.51 13.47 80 38661 225351 53084974
Retching 26.50 13.47 41 38700 13892 53296433
Swollen tongue 26.35 13.47 65 38676 31015 53279310
Dyspnoea 26.20 13.47 286 38455 585946 52724379
Pancytopenia 25.99 13.47 17 38724 90911 53219414
Gastrointestinal disorder 25.50 13.47 17 38724 89987 53220338
Disease progression 25.36 13.47 22 38719 101898 53208427
Unresponsive to stimuli 25.32 13.47 67 38674 33359 53276966
Foetal malformation 25.00 13.47 8 38733 173 53310152
Product prescribing error 24.87 13.47 53 38688 22978 53287347
Cardio-respiratory arrest 24.55 13.47 96 38645 58662 53251663
Oral discomfort 24.51 13.47 31 38710 8715 53301610
Glossitis 24.47 13.47 19 38722 2957 53307368
Sedation 24.04 13.47 61 38680 29614 53280711
Abdominal discomfort 23.53 13.47 82 38659 220980 53089345
Cataract 23.25 13.47 4 38737 49616 53260709
Interstitial lung disease 22.95 13.47 7 38734 58615 53251710
Eyelid retraction 22.94 13.47 6 38735 61 53310264
Impaired healing 22.84 13.47 9 38732 64196 53246129
Bronchitis 22.41 13.47 29 38712 111870 53198455
Tooth hypoplasia 22.35 13.47 6 38735 68 53310257
Tongue erythema 21.98 13.47 8 38733 258 53310067
Pain in extremity 21.67 13.47 120 38621 284930 53025395
Monoplegia 21.60 13.47 18 38723 3097 53307228
Genitourinary symptom 21.52 13.47 6 38735 79 53310246
Therapeutic response shortened 21.41 13.47 26 38715 7013 53303312
Blood cholesterol increased 21.34 13.47 6 38735 52983 53257342
Maternal use of illicit drugs 21.25 13.47 4 38737 6 53310319
Judgement impaired 21.07 13.47 10 38731 636 53309689
Feeling of body temperature change 21.03 13.47 21 38720 4559 53305766
Swelling 20.93 13.47 70 38671 191035 53119290
Neutrophil count decreased 20.84 13.47 5 38736 49093 53261232
Musculoskeletal stiffness 20.80 13.47 36 38705 123332 53186993
Vulvar basal cell carcinoma 20.77 13.47 5 38736 35 53310290
Dyspnoea exertional 20.76 13.47 7 38734 54993 53255332
Bruxism 20.74 13.47 18 38723 3273 53307052
Neurosis 20.69 13.47 8 38733 306 53310019
Accidental poisoning 20.62 13.47 10 38731 667 53309658
Spasmodic dysphonia 20.62 13.47 6 38735 93 53310232
Dependence 20.56 13.47 15 38726 2126 53308199
Accidental overdose 20.45 13.47 47 38694 21432 53288893
Reaction to excipient 19.67 13.47 12 38729 1263 53309062
Headache 19.58 13.47 519 38222 536302 52774023
Congenital coronary artery malformation 19.58 13.47 6 38735 112 53310213
Maternal drugs affecting foetus 19.39 13.47 22 38719 5524 53304801
Oral disorder 19.18 13.47 27 38714 8408 53301917
Endocarditis staphylococcal 19.17 13.47 8 38733 374 53309951
Product dose omission issue 19.12 13.47 73 38668 191547 53118778
Injection site ulcer 18.89 13.47 9 38732 577 53309748
Blood glucose increased 18.88 13.47 17 38724 77344 53232981
Cardiac failure congestive 18.62 13.47 24 38717 92733 53217592
Agitation 18.50 13.47 88 38653 58538 53251787
Product contamination 18.39 13.47 9 38732 612 53309713
Application site infection 18.29 13.47 5 38736 61 53310264
Stomatitis 18.25 13.47 128 38613 98030 53212295
Hepatitis C 18.15 13.47 23 38718 6478 53303847
Wound 18.06 13.47 24 38717 91533 53218792
Injection site erosion 17.99 13.47 5 38736 65 53310260
Dermatitis allergic 17.97 13.47 34 38707 13534 53296791
Skin irritation 17.84 13.47 26 38715 8358 53301967
Radial nerve palsy 17.83 13.47 8 38733 447 53309878
Influenza 17.81 13.47 26 38715 95353 53214972
Irritable bowel syndrome 17.46 13.47 5 38736 43627 53266698
Neonatal aspiration 17.29 13.47 6 38735 168 53310157
Foetal death 17.07 13.47 27 38714 9320 53301005
Application site pustules 17.01 13.47 4 38737 25 53310300
Substance dependence 16.96 13.47 6 38735 178 53310147
Leukopenia 16.92 13.47 17 38724 73446 53236879
Drug dependence, antepartum 16.87 13.47 4 38737 26 53310299
Apathy 16.57 13.47 25 38716 8287 53302038
Sepsis 16.47 13.47 53 38688 146376 53163949
Chondrodystrophy 16.38 13.47 5 38736 92 53310233
Product taste abnormal 16.31 13.47 13 38728 2100 53308225
Weight increased 16.15 13.47 85 38656 204482 53105843
Herpes zoster 16.08 13.47 18 38723 74001 53236324
Application site discomfort 15.95 13.47 7 38734 371 53309954
Taste disorder 15.93 13.47 24 38717 7944 53302381
Drug level decreased 15.88 13.47 22 38719 6752 53303573
Drug effect less than expected 15.75 13.47 7 38734 382 53309943
Gastrointestinal hypomotility 15.74 13.47 10 38731 1131 53309194
Enlarged uvula 15.73 13.47 6 38735 221 53310104
Productive cough 15.68 13.47 11 38730 56718 53253607
Aspartate aminotransferase increased 15.60 13.47 23 38718 84006 53226319
Pulmonary embolism 15.40 13.47 38 38703 114404 53195921
Application site perspiration 15.39 13.47 3 38738 6 53310319
Focal segmental glomerulosclerosis 15.36 13.47 11 38730 1514 53308811
Somnolence neonatal 15.34 13.47 5 38736 115 53310210
Blepharospasm 15.32 13.47 14 38727 2722 53307603
Tremor 15.32 13.47 149 38592 125587 53184738
Ascites 15.10 13.47 5 38736 39730 53270595
Application site laceration 15.08 13.47 3 38738 7 53310318
Small for dates baby 15.05 13.47 16 38725 3736 53306589
Coronary artery disease 15.01 13.47 3 38738 33434 53276891
Malignant neoplasm progression 14.89 13.47 18 38723 71523 53238802
Premature rupture of membranes 14.62 13.47 18 38723 4922 53305403
Dental caries 14.60 13.47 27 38714 10565 53299760
Musculoskeletal pain 14.54 13.47 20 38721 75180 53235145
Injection site oedema 14.45 13.47 9 38732 983 53309342
Insurance issue 14.39 13.47 13 38728 2492 53307833
Lack of application site rotation 14.29 13.47 3 38738 10 53310315
Withdrawal hypertension 14.24 13.47 5 38736 145 53310180
Diabetes mellitus 14.19 13.47 11 38730 53888 53256437
Urinary tract infection 14.16 13.47 109 38632 239794 53070531
Neuropathy peripheral 14.09 13.47 34 38707 103153 53207172
Mouth ulceration 13.98 13.47 50 38691 29276 53281049
Pleural effusion 13.90 13.47 27 38714 88552 53221773
Lack of administration site rotation 13.87 13.47 3 38738 12 53310313
Mental disorder 13.77 13.47 44 38697 24332 53285993
Upper respiratory tract infection 13.74 13.47 18 38723 69079 53241246

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 2216.67 14.44 843 36503 19388 32456792
Drug abuse 1864.91 14.44 1152 36194 79091 32397089
Drug dependence 1681.49 14.44 721 36625 22763 32453417
Intentional product misuse 779.79 14.44 496 36850 35555 32440625
Substance abuse 553.36 14.44 232 37114 6875 32469305
Product adhesion issue 534.07 14.44 154 37192 1405 32474775
Toxicity to various agents 511.61 14.44 808 36538 177233 32298947
Drug withdrawal syndrome neonatal 490.43 14.44 176 37170 3388 32472792
Withdrawal syndrome 466.48 14.44 243 37103 11879 32464301
Miosis 430.80 14.44 207 37139 8497 32467683
Injection site pain 409.70 14.44 324 37022 32734 32443446
Overdose 406.80 14.44 500 36846 86577 32389603
Intentional product use issue 405.51 14.44 357 36989 41854 32434326
Drug use disorder 356.69 14.44 140 37206 3481 32472699
Application site pruritus 344.45 14.44 107 37239 1286 32474894
Drug screen negative 334.56 14.44 75 37271 204 32475976
Intentional underdose 334.46 14.44 94 37252 774 32475406
Alcohol abuse 308.39 14.44 134 37212 4338 32471842
Drug detoxification 297.08 14.44 67 37279 189 32475991
Product solubility abnormal 277.74 14.44 75 37271 523 32475657
Application site rash 265.29 14.44 78 37268 766 32475414
Application site erythema 260.72 14.44 99 37247 2244 32473936
Inadequate analgesia 251.74 14.44 102 37244 2761 32473419
Drug screen positive 237.90 14.44 110 37236 4131 32472049
Product use issue 236.33 14.44 297 37049 52480 32423700
Wrong technique in product usage process 227.43 14.44 239 37107 34820 32441360
Product substitution issue 221.24 14.44 142 37204 10294 32465886
Respiratory depression 195.43 14.44 144 37202 13067 32463113
Application site burn 186.92 14.44 46 37300 209 32475971
Product preparation error 185.86 14.44 73 37273 1817 32474363
Euphoric mood 179.00 14.44 97 37249 5130 32471050
Foetal exposure during pregnancy 176.24 14.44 227 37119 41074 32435106
Coma 170.65 14.44 227 37119 42385 32433795
Injection site infection 170.62 14.44 57 37289 876 32475304
Injection site abscess 161.10 14.44 52 37294 713 32475467
Application site vesicles 160.82 14.44 49 37297 549 32475631
Inappropriate schedule of product administration 160.76 14.44 229 37117 45596 32430584
Injection site ulcer 140.52 14.44 37 37309 231 32475949
Application site pain 138.30 14.44 58 37288 1716 32474464
Accidental exposure to product by child 136.85 14.44 56 37290 1555 32474625
Somnolence 134.08 14.44 338 37008 103459 32372721
Hyperhidrosis 124.17 14.44 261 37085 70907 32405273
Injection site erythema 119.03 14.44 113 37233 14555 32461625
Drug delivery system removal 115.41 14.44 20 37326 0 32476180
Accidental overdose 115.04 14.44 126 37220 19213 32456967
Drug diversion 114.42 14.44 42 37304 863 32475317
Pneumonia 108.84 14.44 150 37196 355102 32121078
Pyrexia 108.51 14.44 125 37221 319843 32156337
Febrile neutropenia 106.82 14.44 8 37338 119558 32356622
Maternal exposure during breast feeding 99.71 14.44 45 37301 1595 32474585
Injection site extravasation 97.37 14.44 50 37296 2366 32473814
Application site irritation 93.75 14.44 34 37312 674 32475506
Oral administration complication 90.02 14.44 21 37325 72 32476108
Asphyxia 89.52 14.44 64 37282 5536 32470644
Nausea 87.29 14.44 648 36698 320201 32155979
Hypotension 82.67 14.44 76 37270 216034 32260146
Atrial fibrillation 82.13 14.44 17 37329 116687 32359493
Diarrhoea 81.88 14.44 187 37159 364615 32111565
Brain oedema 81.55 14.44 87 37259 12873 32463307
Injection site erosion 80.60 14.44 19 37327 69 32476111
Anaemia 79.38 14.44 84 37262 223540 32252640
Injection site necrosis 78.46 14.44 26 37320 389 32475791
Cough 76.28 14.44 32 37314 138785 32337395
Platelet count decreased 74.11 14.44 20 37326 114571 32361609
Therapeutic product effect decreased 72.73 14.44 129 37217 30888 32445292
Jaundice neonatal 70.57 14.44 32 37314 1147 32475033
Agitation 69.25 14.44 182 37164 57054 32419126
Brachial artery entrapment syndrome 69.25 14.44 12 37334 0 32476180
White blood cell count decreased 66.87 14.44 12 37334 91186 32384994
Prescription drug used without a prescription 64.19 14.44 31 37315 1284 32474896
Oral mucosal blistering 63.62 14.44 35 37311 1906 32474274
Endocarditis 61.86 14.44 55 37291 6509 32469671
Cluster headache 61.53 14.44 23 37323 498 32475682
Aggression 61.26 14.44 138 37208 39251 32436929
Application site reaction 61.09 14.44 22 37324 427 32475753
Logorrhoea 60.98 14.44 37 37309 2425 32473755
Application site dryness 60.47 14.44 14 37332 46 32476134
Product colour issue 59.39 14.44 22 37324 464 32475716
Product dosage form issue 59.35 14.44 14 37332 51 32476129
Congenital multiplex arthrogryposis 58.08 14.44 13 37333 35 32476145
Intentional removal of drug delivery system by patient 57.71 14.44 10 37336 0 32476180
Impaired driving ability 57.67 14.44 36 37310 2483 32473697
Injection site discharge 57.47 14.44 15 37331 90 32476090
Injection site vesicles 57.38 14.44 22 37324 512 32475668
Cardiac failure congestive 56.39 14.44 14 37332 84838 32391342
Poor feeding infant 55.53 14.44 21 37325 470 32475710
Therapeutic product effect increased 54.23 14.44 23 37323 700 32475480
Bradypnoea 53.09 14.44 34 37312 2452 32473728
Dermo-hypodermitis 53.03 14.44 18 37328 291 32475889
Exposure via breast milk 52.29 14.44 30 37316 1772 32474408
Cerebrovascular accident 52.26 14.44 17 37329 86303 32389877
Application site urticaria 51.97 14.44 13 37333 64 32476116
Haemoglobin decreased 50.73 14.44 38 37308 119633 32356547
Anxiety 49.54 14.44 230 37116 95775 32380405
Dysarthria 49.05 14.44 114 37232 33087 32443093
Aptyalism 48.87 14.44 17 37329 297 32475883
Fatigue 48.40 14.44 223 37123 350478 32125702
Drug effect less than expected 48.29 14.44 15 37331 180 32476000
Hepatitis C 47.99 14.44 68 37278 13450 32462730
Deafness neurosensory 47.62 14.44 33 37313 2715 32473465
Neutropenia 47.53 14.44 56 37290 142119 32334061
Tongue blistering 47.41 14.44 16 37330 254 32475926
Application site swelling 47.35 14.44 16 37330 255 32475925
Restlessness 46.56 14.44 94 37252 24787 32451393
Acute kidney injury 46.41 14.44 177 37169 293291 32182889
Vomiting 46.39 14.44 443 36903 235114 32241066
Pleural effusion 45.34 14.44 17 37329 78975 32397205
Product taste abnormal 45.18 14.44 24 37322 1218 32474962
Dependence 44.98 14.44 24 37322 1229 32474951
Arthralgia 44.94 14.44 63 37283 148385 32327795
Disease progression 44.59 14.44 22 37324 86840 32389340
Blood creatinine increased 44.09 14.44 28 37318 96104 32380076
Tremor neonatal 44.08 14.44 17 37329 402 32475778
Injection site cellulitis 43.80 14.44 18 37328 505 32475675
Dyspnoea 43.79 14.44 241 37105 361804 32114376
Sarcopenia 42.99 14.44 16 37330 342 32475838
Product formulation issue 42.90 14.44 18 37328 533 32475647
Interstitial lung disease 42.65 14.44 11 37335 64990 32411190
Accidental poisoning 42.40 14.44 18 37328 549 32475631
Application site exfoliation 41.94 14.44 12 37334 106 32476074
Product packaging quantity issue 41.81 14.44 20 37326 811 32475369
Malignant neoplasm progression 41.64 14.44 19 37327 78477 32397703
Application site discolouration 41.38 14.44 14 37332 224 32475956
Glomerulonephritis acute 40.94 14.44 11 37335 75 32476105
Sedation 40.80 14.44 75 37271 18451 32457729
Endocarditis staphylococcal 40.58 14.44 16 37330 402 32475778
Injection site irritation 40.57 14.44 21 37325 1010 32475170
Injection site warmth 40.35 14.44 26 37320 1895 32474285
Asthenia 40.11 14.44 138 37208 235806 32240374
Thrombocytopenia 40.04 14.44 68 37278 148231 32327949
Poisoning 39.42 14.44 56 37290 11102 32465078
Feeling abnormal 39.04 14.44 155 37191 60268 32415912
Low birth weight baby 38.88 14.44 44 37302 6950 32469230
Neuropathy peripheral 38.76 14.44 20 37326 76962 32399218
Suicidal ideation 38.05 14.44 113 37233 37970 32438210
Product dispensing issue 37.63 14.44 10 37336 65 32476115
Epistaxis 37.52 14.44 9 37337 55846 32420334
Drug abuser 37.34 14.44 34 37312 4150 32472030
Premature baby 37.10 14.44 72 37274 18446 32457734
Renal failure 36.91 14.44 61 37285 134417 32341763
Dehydration 36.80 14.44 57 37289 128901 32347279
Hyponatraemia 36.57 14.44 20 37326 74493 32401687
Disorientation 36.11 14.44 102 37244 33323 32442857
Incorrect route of product administration 35.87 14.44 55 37291 11671 32464509
Infusion related reaction 35.66 14.44 5 37341 45594 32430586
Application site erosion 35.50 14.44 10 37336 83 32476097
Aspartate aminotransferase increased 35.36 14.44 16 37330 66413 32409767
Hyperkalaemia 35.29 14.44 18 37328 69732 32406448
Congestive hepatopathy 35.28 14.44 24 37322 1916 32474264
Pulmonary oedema 35.13 14.44 125 37221 46142 32430038
Decreased gait velocity 34.90 14.44 11 37335 139 32476041
Application site scar 34.86 14.44 8 37338 25 32476155
Blood glucose increased 34.28 14.44 16 37330 65225 32410955
Application site discharge 34.26 14.44 11 37335 148 32476032
Road traffic accident 34.11 14.44 67 37279 17314 32458866
Housebound 33.96 14.44 12 37334 220 32475960
Headache 33.76 14.44 359 36987 195838 32280342
Coronary artery disease 33.40 14.44 8 37338 49698 32426482
Substance use 33.28 14.44 15 37331 530 32475650
Product physical issue 33.25 14.44 25 37321 2336 32473844
Purpura fulminans 32.74 14.44 10 37336 113 32476067
Feeding intolerance 32.69 14.44 9 37337 68 32476112
Gastrointestinal haemorrhage 32.62 14.44 31 37315 86851 32389329
Pancytopenia 32.59 14.44 34 37312 91201 32384979
Prescription form tampering 32.41 14.44 15 37331 564 32475616
Application site hypersensitivity 32.12 14.44 10 37336 121 32476059
Product administered at inappropriate site 32.11 14.44 22 37324 1777 32474403
Injection site inflammation 31.88 14.44 16 37330 721 32475459
Prescribed overdose 31.04 14.44 46 37300 9473 32466707
Renal impairment 30.95 14.44 36 37310 91936 32384244
Injection site swelling 30.80 14.44 46 37300 9538 32466642
Substance use disorder 30.67 14.44 11 37335 211 32475969
Plasma cell myeloma 30.47 14.44 14 37332 57600 32418580
Injection site pruritus 29.99 14.44 36 37310 6054 32470126
Sepsis 29.68 14.44 89 37257 158745 32317435
Haemorrhage 29.46 14.44 10 37336 49438 32426742
Myocardial infarction 29.21 14.44 63 37283 125613 32350567
International normalised ratio increased 29.07 14.44 10 37336 49025 32427155
Respiratory rate decreased 28.71 14.44 21 37325 1881 32474299
Psoriasis 28.05 14.44 9 37337 46114 32430066
Vestibular ischaemia 27.42 14.44 6 37340 14 32476166
Depressed level of consciousness 27.36 14.44 106 37240 40741 32435439
Neutrophil count decreased 27.28 14.44 10 37336 47129 32429051
Product dose omission issue 26.78 14.44 48 37298 102527 32373653
Thermophobia 26.30 14.44 8 37338 89 32476091
Skin irritation 26.18 14.44 30 37316 4801 32471379
Foetal distress syndrome 26.03 14.44 16 37330 1073 32475107
Thrombosis 25.99 14.44 10 37336 45744 32430436
Unresponsive to stimuli 25.77 14.44 80 37266 27529 32448651
Bradyphrenia 25.52 14.44 29 37317 4600 32471580
Breech presentation 25.42 14.44 9 37337 166 32476014
Ear deformity acquired 25.39 14.44 5 37341 5 32476175
Joint swelling 25.21 14.44 14 37332 51721 32424459
Disturbance in attention 25.18 14.44 72 37274 23681 32452499
Hallucination 24.89 14.44 123 37223 52496 32423684
Infection 24.58 14.44 37 37309 84678 32391502
Substance dependence 24.55 14.44 11 37335 383 32475797
Respiratory arrest 24.47 14.44 81 37265 28827 32447353
Application site scab 24.45 14.44 7 37339 62 32476118
General physical health deterioration 24.19 14.44 61 37285 115198 32360982
Cerebral congestion 24.07 14.44 6 37340 29 32476151
Joint hyperextension 23.87 14.44 7 37339 68 32476112
Weight increased 23.83 14.44 37 37309 83626 32392554
Hypertension 23.76 14.44 75 37271 131675 32344505
Drug interaction 23.41 14.44 366 36980 217819 32258361
Rectal haemorrhage 23.30 14.44 7 37339 37416 32438764
Mucosal inflammation 23.23 14.44 5 37341 33429 32442751
Urinary tract infection 23.20 14.44 35 37311 80036 32396144
Troponin T increased 23.16 14.44 17 37329 1531 32474649
Septic pulmonary embolism 23.08 14.44 4 37342 0 32476180
Accidental exposure to product 22.98 14.44 44 37302 11158 32465022
Therapy naive 22.75 14.44 5 37341 12 32476168
Acute myocardial infarction 22.73 14.44 18 37328 55131 32421049
Herpes zoster 22.13 14.44 5 37341 32336 32443844
Bronchitis 22.08 14.44 10 37336 41497 32434683
COVID-19 21.81 14.44 5 37341 32010 32444170
Product use in unapproved indication 21.71 14.44 42 37304 87162 32389018
Blood bilirubin increased 21.17 14.44 9 37337 38775 32437405
Clumsiness 21.14 14.44 16 37330 1510 32474670
Vestibular disorder 20.99 14.44 14 37332 1082 32475098
Product physical consistency issue 20.94 14.44 10 37336 404 32475776
Agitation neonatal 20.92 14.44 14 37332 1088 32475092
Back pain 20.89 14.44 62 37284 110991 32365189
Chronic actinic dermatitis 20.63 14.44 5 37341 21 32476159
Skull fracture 20.38 14.44 13 37333 931 32475249
Rheumatoid arthritis 20.37 14.44 13 37333 44531 32431649
Drug reaction with eosinophilia and systemic symptoms 20.36 14.44 6 37340 32479 32443701
Injection site bruising 20.25 14.44 34 37312 7786 32468394
Libido decreased 20.20 14.44 26 37320 4692 32471488
Embolia cutis medicamentosa 19.96 14.44 8 37338 210 32475970
Psychotic disorder 19.93 14.44 65 37281 22955 32453225
Brief psychotic disorder with marked stressors 19.89 14.44 8 37338 212 32475968
Rash maculo-papular 19.86 14.44 4 37342 28018 32448162
Hypoxic-ischaemic encephalopathy 19.61 14.44 26 37320 4828 32471352
Diabetes mellitus 19.57 14.44 14 37332 45159 32431021
Cyanosis 19.52 14.44 44 37302 12509 32463671
Blood pressure decreased 19.43 14.44 18 37328 51062 32425118
Hyperglycaemia 19.28 14.44 10 37336 38381 32437799
Infantile vomiting 19.16 14.44 5 37341 30 32476150
Pulmonary congestion 19.15 14.44 45 37301 13146 32463034
Mastication disorder 18.92 14.44 14 37332 1277 32474903
Abdominal pain 18.84 14.44 98 37248 149431 32326749
Delirium 18.76 14.44 100 37246 43946 32432234
Chest discomfort 18.75 14.44 18 37328 50212 32425968
Acute respiratory failure 18.57 14.44 5 37341 28723 32447457
Victim of crime 18.45 14.44 9 37337 381 32475799
Hallucinations, mixed 18.39 14.44 19 37327 2708 32473472
Dyspnoea exertional 18.33 14.44 11 37335 38950 32437230
Incoherent 18.30 14.44 24 37322 4410 32471770
Accidental death 18.09 14.44 17 37329 2160 32474020
Pain in extremity 17.90 14.44 73 37273 118828 32357352
Piloerection 17.75 14.44 7 37339 176 32476004
Pain 17.64 14.44 308 37038 187248 32288932
Application site haemorrhage 17.40 14.44 9 37337 432 32475748
Tachyphrenia 17.36 14.44 13 37333 1207 32474973
Abdominal distension 17.33 14.44 20 37326 51275 32424905
Application site odour 17.31 14.44 3 37343 0 32476180
Injection site ischaemia 17.31 14.44 3 37343 0 32476180
Respiratory failure 17.29 14.44 64 37282 107118 32369062
Drug tolerance 17.16 14.44 17 37329 2304 32473876
Needle track marks 17.08 14.44 4 37342 14 32476166
Micrognathia 17.01 14.44 8 37338 312 32475868
Tongue discomfort 16.99 14.44 9 37337 454 32475726
Wrong dose 16.97 14.44 9 37337 455 32475725
Colitis 16.81 14.44 9 37337 33942 32442238
Axillary pain 16.80 14.44 8 37338 321 32475859
Oral discomfort 16.79 14.44 18 37328 2677 32473503
Emotional poverty 16.67 14.44 9 37337 472 32475708
Application site ulcer 16.66 14.44 4 37342 16 32476164
Mydriasis 16.66 14.44 28 37318 6418 32469762
Cardiac failure 16.65 14.44 52 37294 91621 32384559
Coordination abnormal 16.59 14.44 31 37315 7717 32468463
Chronic kidney disease 16.53 14.44 13 37333 39962 32436218
Insomnia 16.46 14.44 182 37164 100166 32376014
Rash 16.19 14.44 158 37188 209175 32267005
Gun shot wound 16.03 14.44 12 37334 1114 32475066
Product contamination 15.87 14.44 10 37336 701 32475479
Upper respiratory tract infection 15.83 14.44 7 37339 29466 32446714
Transient ischaemic attack 15.74 14.44 5 37341 25789 32450391
Haematoma 15.63 14.44 5 37341 25679 32450501
Deep vein thrombosis 15.58 14.44 31 37315 63682 32412498
Prostate cancer 15.54 14.44 6 37340 27400 32448780
Alcohol interaction 15.53 14.44 16 37330 2273 32473907
Multiple cardiac defects 15.46 14.44 5 37341 69 32476111
Neonatal aspiration 15.39 14.44 5 37341 70 32476110
Persecutory delusion 15.24 14.44 16 37330 2323 32473857
Administration site abscess sterile 15.24 14.44 3 37343 3 32476177
Medical observation 15.24 14.44 3 37343 3 32476177
Dermal absorption impaired 15.24 14.44 3 37343 3 32476177
Formication 15.18 14.44 14 37332 1737 32474443
Injection site induration 15.11 14.44 17 37329 2667 32473513
Alcohol withdrawal syndrome 15.06 14.44 13 37333 1478 32474702
Acute cardiac event 15.05 14.44 4 37342 26 32476154
C-reactive protein increased 14.95 14.44 20 37326 48082 32428098
Eosinophilia 14.94 14.44 5 37341 24953 32451227
Irritability 14.92 14.44 62 37284 24592 32451588
Adrenocorticotropic hormone deficiency 14.86 14.44 9 37337 588 32475592
Haematocrit decreased 14.81 14.44 9 37337 31653 32444527
Injection site scab 14.80 14.44 4 37342 28 32476152
Drug level below therapeutic 14.74 14.44 21 37325 4174 32472006
Palatal disorder 14.71 14.44 6 37340 165 32476015
Restless legs syndrome 14.49 14.44 29 37317 7595 32468585
Erythema 14.49 14.44 48 37298 83057 32393123

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 analgesics
CHEBI has role CHEBI:55322 mu opioid agonist
CHEBI has role CHEBI:59283 delta-opioid antagonists
CHEBI has role CHEBI:167165 kappa-opioid antagonist
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

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
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
1819 RXNORM
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 0054-0177 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 0054-0189 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 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 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
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7009 TABLET 2 mg SUBLINGUAL ANDA 32 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7010 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0904-7154 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0904-7155 TABLET 8 mg SUBLINGUAL ANDA 33 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0100 SOLUTION 100 mg SUBCUTANEOUS NDA 33 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0300 SOLUTION 300 mg SUBCUTANEOUS NDA 33 sections
Buprenex HUMAN PRESCRIPTION DRUG LABEL 1 12496-0757 INJECTION 0.30 mg INTRAVENOUS NDA 28 sections
Suboxone HUMAN PRESCRIPTION DRUG LABEL 2 12496-1202 FILM, SOLUBLE 2 mg SUBLINGUAL NDA 31 sections