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
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
Toxicity to various agents 400.12 39.22 136 1337 32618 2323994
Maternal exposure during pregnancy 362.76 39.22 105 1368 14758 2341854
Exposure during pregnancy 312.03 39.22 106 1367 25113 2331499
Drug abuse 244.77 39.22 74 1399 11952 2344660
Drug withdrawal syndrome 182.62 39.22 52 1421 6769 2349843
Respiratory depression 164.64 39.22 38 1435 2132 2354480
Cardio-respiratory arrest 154.98 39.22 49 1424 9097 2347515
Completed suicide 145.94 39.22 58 1415 20976 2335636
Respiratory arrest 129.52 39.22 39 1434 6139 2350473
Intentional product misuse 128.84 39.22 43 1430 9446 2347166
Drug withdrawal syndrome neonatal 123.74 39.22 23 1450 434 2356178
Drug dependence 122.34 39.22 32 1441 3013 2353599
Premature delivery 120.76 39.22 32 1441 3168 2353444
Nausea 120.47 39.22 89 1384 112100 2244512
Death 118.62 39.22 78 1395 81390 2275222
Overdose 117.76 39.22 49 1424 19858 2336754
Placental disorder 117.70 39.22 21 1452 312 2356300
Placental hypertrophy 113.59 39.22 14 1459 4 2356608
Somnolence 106.75 39.22 48 1425 23437 2333175
Foetal exposure during pregnancy 100.82 39.22 31 1442 5221 2351391
Vomiting 100.27 39.22 67 1406 71535 2285077
Confusional state 86.53 39.22 42 1431 24302 2332310
Depressed level of consciousness 81.86 39.22 29 1444 7575 2349037
Substance abuse 77.32 39.22 16 1457 533 2356079
Product adhesion issue 74.33 39.22 18 1455 1234 2355378
Product solubility abnormal 73.35 39.22 13 1460 185 2356427
Cardiac arrest 69.25 39.22 31 1442 14899 2341713
Drug ineffective 69.11 39.22 62 1411 101562 2255050
Dizziness 65.75 39.22 48 1425 58617 2297995
Product use issue 65.28 39.22 28 1445 12141 2344471
Withdrawal syndrome 65.27 39.22 20 1453 3317 2353295
Stress cardiomyopathy 61.74 39.22 16 1457 1445 2355167
Hallucination 61.66 39.22 24 1449 8124 2348488
Dermatitis allergic 60.91 39.22 17 1456 2034 2354578
Delirium 60.30 39.22 21 1452 5202 2351410
Abortion spontaneous 59.41 39.22 27 1446 13418 2343194
Coma 59.20 39.22 24 1449 9032 2347580
Maternal exposure during breast feeding 59.06 39.22 13 1460 583 2356029
Hyperhidrosis 58.92 39.22 28 1445 15394 2341218
Drug screen positive 58.59 39.22 14 1459 906 2355706
Bradycardia foetal 58.38 39.22 10 1463 115 2356497
Drug interaction 57.43 39.22 34 1439 29129 2327483
Hyperaesthesia 54.40 39.22 14 1459 1229 2355383
Inadequate analgesia 52.87 39.22 12 1461 619 2355993
Constipation 52.72 39.22 29 1444 21600 2335012
Abortion induced 52.25 39.22 17 1456 3419 2353193
17 ketosteroids urine abnormal 50.17 39.22 6 1467 0 2356612
Accidental overdose 49.84 39.22 17 1456 3955 2352657
Product substitution issue 49.49 39.22 18 1455 5051 2351561
Sedation 48.57 39.22 16 1457 3346 2353266
Foetal death 48.43 39.22 14 1459 1898 2354714
Loss of consciousness 45.27 39.22 25 1448 18742 2337870
Agitation 45.06 39.22 21 1452 11030 2345582
Miosis 44.97 39.22 12 1461 1212 2355400
Gastrointestinal hypomotility 44.38 39.22 9 1464 270 2356342
Accidental death 43.18 39.22 9 1464 310 2356302
Product physical consistency issue 43.05 39.22 8 1465 150 2356462
Fall 42.65 39.22 34 1439 47065 2309547
Foetal malformation 41.67 39.22 7 1466 71 2356541
Tachycardia 39.95 39.22 22 1451 16387 2340225

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
Toxicity to various agents 1142.47 47.45 351 1619 28790 1716021
Drug abuse 1018.88 47.45 273 1697 13416 1731395
Intentional product misuse 664.34 47.45 172 1798 7186 1737625
Drug dependence 358.74 47.45 90 1880 3237 1741574
Overdose 352.17 47.45 128 1842 16573 1728238
Accidental overdose 268.41 47.45 75 1895 4089 1740722
Death 262.32 47.45 176 1794 87267 1657544
Drug withdrawal syndrome 262.24 47.45 75 1895 4450 1740361
Substance abuse 246.06 47.45 53 1917 950 1743861
Respiratory depression 184.32 47.45 49 1921 2198 1742613
Drug withdrawal syndrome neonatal 166.63 47.45 36 1934 652 1744159
Drug screen positive 161.70 47.45 38 1932 1019 1743792
Foetal exposure during pregnancy 156.82 47.45 55 1915 6304 1738507
Prescription drug used without a prescription 146.67 47.45 27 1943 203 1744608
Intentional product use issue 143.58 47.45 42 1928 2677 1742134
Dysarthria 143.21 47.45 49 1921 5210 1739601
Alcohol abuse 143.21 47.45 31 1939 566 1744245
Miosis 129.57 47.45 34 1936 1444 1743367
Pulmonary oedema 128.75 47.45 48 1922 6538 1738273
Brain oedema 125.13 47.45 36 1934 2160 1742651
Drug interaction 124.62 47.45 73 1897 27885 1716926
Deafness neurosensory 122.52 47.45 27 1943 537 1744274
Somnolence 108.40 47.45 56 1914 16683 1728128
Drug use disorder 105.14 47.45 23 1947 441 1744370
Asphyxia 105.00 47.45 27 1943 1056 1743755
Agitation 101.70 47.45 47 1923 10979 1733832
Withdrawal syndrome 93.38 47.45 29 1941 2259 1742552
Cardio-respiratory arrest 83.74 47.45 39 1931 9254 1735557
Nausea 80.68 47.45 71 1899 51125 1693686
Confusional state 80.23 47.45 50 1920 21228 1723583
Accidental death 79.65 47.45 18 1952 402 1744409
Pneumonia aspiration 76.60 47.45 31 1939 5235 1739576
Unresponsive to stimuli 73.39 47.45 29 1941 4600 1740211
Hyperhidrosis 72.81 47.45 39 1931 12449 1732362
Disorientation 72.07 47.45 30 1940 5439 1739372
Delirium 70.94 47.45 31 1939 6331 1738480
Respiratory arrest 70.17 47.45 30 1940 5809 1739002
Pulmonary congestion 69.96 47.45 22 1948 1783 1743028
Cyanosis 69.12 47.45 24 1946 2650 1742161
Hepatic congestion 68.04 47.45 15 1955 298 1744513
Logorrhoea 66.34 47.45 16 1954 478 1744333
Vomiting 66.03 47.45 56 1914 38259 1706552
Medication error 65.81 47.45 27 1943 4716 1740095
Completed suicide 63.11 47.45 39 1931 16273 1728538
Cluster headache 61.99 47.45 12 1958 121 1744690
Vestibular disorder 58.37 47.45 12 1958 168 1744643
Troponin T increased 57.87 47.45 13 1957 282 1744529
Memory impairment 56.99 47.45 27 1943 6636 1738175
Coordination abnormal 56.98 47.45 18 1952 1479 1743332
Incorrect route of product administration 55.92 47.45 22 1948 3443 1741368
Drug-induced liver injury 53.81 47.45 21 1949 3216 1741595
Persecutory delusion 52.64 47.45 13 1957 429 1744382
Coma 51.82 47.45 26 1944 7236 1737575
Restlessness 51.23 47.45 22 1948 4299 1740512
Hallucination 48.92 47.45 26 1944 8144 1736667
Exposure via breast milk 48.27 47.45 11 1959 255 1744556
Intentional overdose 47.60 47.45 25 1945 7645 1737166

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
FDA EPC N0000175689 Partial Opioid Agonist
FDA MoA N0000175685 Partial Opioid Agonists
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
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
CHEBI has role CHEBI:59282 kappa-opioid receptor agonist
CHEBI has role CHEBI:59283 delta-opioid receptor antagonist

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 2.1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 7579019 Jan. 22, 2020 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 7579019 Jan. 22, 2020 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 7579019 Jan. 22, 2020 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.15MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.3MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.45MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.6MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.75MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.9MG BASE BELBUCA BDSI N207932 Oct. 23, 2015 RX FILM BUCCAL 7579019 Jan. 22, 2020 TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 12MG 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 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 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 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 RX IMPLANT IMPLANTATION 7736665 April 25, 2024 FOR OPIOID DEPENDENCE
EQ 2.1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2.1MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 9655843 July 23, 2027 TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX FILM BUCCAL 8147866 July 23, 2027 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE BUNAVAIL BDSI N205637 June 6, 2014 RX 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 0.075MG 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MCG/HR BUTRANS PURDUE PHARMA LP N021306 June 30, 2010 RX FILM, EXTENDED RELEASE TRANSDERMAL Oct. 13, 2020 REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1
15MCG/HR BUTRANS PURDUE PHARMA LP N021306 July 25, 2013 RX FILM, EXTENDED RELEASE TRANSDERMAL Oct. 13, 2020 REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1
20MCG/HR BUTRANS PURDUE PHARMA LP N021306 June 30, 2010 RX FILM, EXTENDED RELEASE TRANSDERMAL Oct. 13, 2020 REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1
5MCG/HR BUTRANS PURDUE PHARMA LP N021306 June 30, 2010 RX FILM, EXTENDED RELEASE TRANSDERMAL Oct. 13, 2020 REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1
7.5MCG/HR BUTRANS PURDUE PHARMA LP N021306 June 30, 2014 RX FILM, EXTENDED RELEASE TRANSDERMAL Oct. 13, 2020 REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1
100MG/0.5ML (100MG/0.5ML) SUBLOCADE INDIVIOR INC N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS Nov. 30, 2020 NEW PRODUCT
300MG/1.5ML (200MG/ML) SUBLOCADE INDIVIOR INC N209819 Nov. 30, 2017 RX SOLUTION, EXTENDED RELEASE SUBCUTANEOUS Nov. 30, 2020 NEW PRODUCT

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 19 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 19 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 19 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 19 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3656 PATCH, EXTENDED RELEASE 5 ug TRANSDERMAL ANDA 21 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3657 PATCH, EXTENDED RELEASE 10 ug TRANSDERMAL ANDA 21 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3658 PATCH, EXTENDED RELEASE 15 ug TRANSDERMAL ANDA 21 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3659 PATCH, EXTENDED RELEASE 20 ug TRANSDERMAL ANDA 21 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 13 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3153 TABLET 8 mg SUBLINGUAL ANDA 19 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 2 mg SUBLINGUAL ANDA 19 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 8 mg SUBLINGUAL ANDA 19 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3156 TABLET 2 mg SUBLINGUAL ANDA 19 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8765 FILM 2 mg SUBLINGUAL ANDA 18 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8766 FILM 4 mg SUBLINGUAL ANDA 18 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8767 FILM 8 mg SUBLINGUAL ANDA 18 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8768 FILM 12 mg SUBLINGUAL ANDA 18 sections
Buprenorphine HCl and Naloxone HCl HUMAN PRESCRIPTION DRUG LABEL 2 0406-1923 TABLET 2 mg SUBLINGUAL ANDA 18 sections
Buprenorphine HCl and Naloxone HCl HUMAN PRESCRIPTION DRUG LABEL 2 0406-1924 TABLET 8 mg SUBLINGUAL ANDA 18 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8005 TABLET 2 mg SUBLINGUAL ANDA 19 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8020 TABLET 8 mg SUBLINGUAL ANDA 19 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2012 INJECTION, SOLUTION 0.30 mg INTRAMUSCULAR ANDA 15 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-0725 INJECTION, SOLUTION 0.32 mg INTRAMUSCULAR ANDA 13 sections
BUPRENORPHINE AND NALOXONE HUMAN PRESCRIPTION DRUG LABEL 2 0781-7216 FILM, SOLUBLE 2 mg SUBLINGUAL NDA authorized generic 18 sections
BUPRENORPHINE AND NALOXONE HUMAN PRESCRIPTION DRUG LABEL 2 0781-7227 FILM, SOLUBLE 4 mg SUBLINGUAL NDA authorized generic 18 sections
BUPRENORPHINE AND NALOXONE HUMAN PRESCRIPTION DRUG LABEL 2 0781-7238 FILM, SOLUBLE 8 mg SUBLINGUAL NDA authorized generic 18 sections
BUPRENORPHINE AND NALOXONE HUMAN PRESCRIPTION DRUG LABEL 2 0781-7249 FILM, SOLUBLE 12 mg SUBLINGUAL NDA authorized generic 18 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0100 SOLUTION 100 mg SUBCUTANEOUS NDA 20 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0300 SOLUTION 300 mg SUBCUTANEOUS NDA 20 sections
Buprenex HUMAN PRESCRIPTION DRUG LABEL 1 12496-0757 INJECTION 0.30 mg INTRAVENOUS NDA 14 sections