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

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists related to normorphine 1878 465-65-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • naloxone hydrochloride dihydrate
  • naloxone hydrochloride hydrate
  • naloxone hydrobromide
  • evzio
  • naloxone
  • l-naloxone
  • (-)-Naloxone
  • naloxone hydrochloride
  • naloxone HCl
A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
  • Molecular weight: 327.38
  • Formula: C19H21NO4
  • CLOGP: 0.16
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 70
  • ALOGS: -1.76
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
75 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.31 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 2 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 23 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.54 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 13, 1971 FDA ADAPT

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
Exposure during pregnancy 254.12 15.30 186 7997 120829 50476112
Abortion spontaneous 139.93 15.30 86 8097 41686 50555255
Drug withdrawal syndrome neonatal 108.74 15.30 30 8153 1811 50595130
Drug withdrawal syndrome 100.53 15.30 58 8125 25023 50571918
Overdose 97.20 15.30 99 8084 99628 50497313
Respiratory depression 86.08 15.30 41 8142 11969 50584972
Toxicity to various agents 79.25 15.30 131 8052 212368 50384573
Selective abortion 74.06 15.30 14 8169 147 50596794
Premature delivery 72.33 15.30 46 8137 23617 50573324
Unresponsive to stimuli 57.18 15.30 44 8139 30565 50566376
Miosis 56.02 15.30 25 8158 6285 50590656
Coma 50.90 15.30 54 8129 56825 50540116
Bradypnoea 50.74 15.30 19 8164 3055 50593886
Abortion induced 49.53 15.30 26 8157 9318 50587623
Thymus disorder 46.07 15.30 10 8173 218 50596723
Suicide attempt 44.32 15.30 48 8135 51684 50545257
Maternal exposure during pregnancy 43.48 15.30 86 8097 159692 50437249
Intestinal infarction 39.71 15.30 12 8171 1000 50595941
Renal infarct 36.22 15.30 12 8171 1348 50595593
Respiratory rate decreased 33.09 15.30 14 8169 3094 50593847
Apnoea 33.03 15.30 18 8165 6948 50589993
Respiratory alkalosis 32.44 15.30 13 8170 2506 50594435
Foetal exposure during pregnancy 29.99 15.30 29 8154 27330 50569611
Mental status changes 29.92 15.30 33 8150 36239 50560702
Depressed level of consciousness 27.81 15.30 38 8145 51915 50545026
Somnolence 27.09 15.30 70 8113 154915 50442026
Aplastic anaemia 26.11 15.30 16 8167 7687 50589254
Generalised anxiety disorder 25.56 15.30 10 8173 1810 50595131
Delirium 25.23 15.30 31 8152 38161 50558780
Sinus tachycardia 24.09 15.30 23 8160 21331 50575610
Withdrawal syndrome 23.85 15.30 21 8162 17569 50579372
Tachyphylaxis 23.72 15.30 6 8177 258 50596683
Electrocardiogram QT prolonged 23.42 15.30 35 8148 51851 50545090
Substance abuse 23.36 15.30 12 8171 4112 50592829
Encephalopathy 23.30 15.30 28 8155 33683 50563258
Premature baby 23.10 15.30 21 8162 18316 50578625
Cardiac arrest 22.68 15.30 45 8138 83606 50513335
Blood albumin decreased 22.49 15.30 18 8165 13218 50583723
Alopecia 22.37 15.30 6 8177 245041 50351900
Bradycardia 21.64 15.30 38 8145 64388 50532553
Hypoaesthesia teeth 20.99 15.30 4 8179 44 50596897
Respiratory acidosis 19.11 15.30 12 8171 6016 50590925
Rhesus incompatibility 18.31 15.30 4 8179 90 50596851
Hepatic necrosis 18.04 15.30 11 8172 5237 50591704
Insulin resistance 17.87 15.30 6 8177 702 50596239
Metastatic gastric cancer 17.24 15.30 4 8179 119 50596822
Impaired insulin secretion 16.72 15.30 3 8180 23 50596918
Appetite disorder 16.50 15.30 11 8172 6103 50590838
Hyporesponsive to stimuli 16.13 15.30 6 8177 946 50595995
Hypotension 16.11 15.30 78 8105 235391 50361550
Accidental exposure to product by child 15.62 15.30 6 8177 1034 50595907
Therapy naive 15.58 15.30 3 8180 35 50596906
Drug intolerance 15.57 15.30 8 8175 219096 50377845
Pelvic haematoma 15.49 15.30 5 8178 517 50596424

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 149.71 16.27 75 6458 17909 29550085
Drug withdrawal syndrome neonatal 144.26 16.27 46 6487 3349 29564645
Overdose 93.45 16.27 101 6432 79718 29488276
Unresponsive to stimuli 83.86 16.27 58 6475 25068 29542926
Non-cardiogenic pulmonary oedema 64.93 16.27 17 6516 610 29567384
Miosis 62.49 16.27 32 6501 7977 29560017
Respiratory depression 56.68 16.27 36 6497 13487 29554507
Maternal exposure during breast feeding 42.68 16.27 15 6518 1471 29566523
Foetal exposure during pregnancy 41.54 16.27 44 6489 33823 29534171
Toxicity to various agents 35.44 16.27 101 6432 173560 29394434
Drug dependence 34.52 16.27 32 6501 20949 29547045
Cerebral congestion 34.47 16.27 6 6527 26 29567968
Therapy naive 30.98 16.27 5 6528 12 29567982
Substance abuse 30.77 16.27 19 6514 6768 29561226
Cardiac arrest 28.33 16.27 60 6473 85531 29482463
Hypopnoea 26.15 16.27 10 6523 1244 29566750
Accidental exposure to product by child 25.40 16.27 10 6523 1344 29566650
Lethargy 25.18 16.27 36 6497 37544 29530450
Accidental exposure to product 25.01 16.27 20 6513 10733 29557261
Brain oedema 24.81 16.27 21 6512 12199 29555795
Counterfeit product administered 24.34 16.27 6 6527 168 29567826
Brief psychotic disorder with marked stressors 23.60 16.27 6 6527 191 29567803
Agitation 23.12 16.27 41 6492 51263 29516731
Pulmonary oedema 21.68 16.27 36 6497 42699 29525295
Drug abuse 20.86 16.27 51 6482 79832 29488162
Axillary pain 20.63 16.27 6 6527 319 29567675
Intentional product misuse 20.05 16.27 31 6502 34630 29533364
Bradypnoea 20.02 16.27 10 6523 2361 29565633
Compartment syndrome 19.71 16.27 10 6523 2442 29565552
Somnolence 19.45 16.27 55 6478 93900 29474094
Hypercapnia 18.35 16.27 11 6522 3715 29564279
Hallucination 17.95 16.27 34 6499 44678 29523316
Seizure 17.81 16.27 53 6480 93070 29474924
Pancreatic disorder 17.59 16.27 8 6525 1535 29566459
Restrictive cardiomyopathy 17.00 16.27 6 6527 595 29567399
Grimacing 16.96 16.27 5 6528 279 29567715
Road traffic accident 16.94 16.27 19 6514 15542 29552452
Pupil fixed 16.87 16.27 8 6525 1688 29566306
Acute on chronic liver failure 16.63 16.27 4 6529 101 29567893
Withdrawal syndrome 16.61 16.27 16 6517 10976 29557018
Delusion 16.34 16.27 16 6517 11200 29556794

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug withdrawal syndrome 174.22 15.01 93 11453 31198 64455988
Overdose 162.66 15.01 170 11376 159396 64327790
Respiratory depression 142.77 15.01 74 11472 23369 64463817
Unresponsive to stimuli 135.65 15.01 94 11452 50299 64436887
Miosis 123.49 15.01 56 11490 13210 64473976
Toxicity to various agents 98.50 15.01 207 11339 363306 64123880
Bradypnoea 71.92 15.01 29 11517 5130 64482056
Non-cardiogenic pulmonary oedema 60.41 15.01 18 11528 1290 64485896
Coma 50.52 15.01 70 11476 87545 64399641
Cardiac arrest 49.04 15.01 94 11452 153970 64333216
Somnolence 45.97 15.01 108 11438 203537 64283649
Thymus disorder 45.02 15.01 10 11536 219 64486967
Suicide attempt 42.84 15.01 58 11488 70949 64416237
Accidental exposure to product by child 41.78 15.01 16 11530 2469 64484717
Depressed level of consciousness 40.99 15.01 61 11485 81375 64405811
Exposure during pregnancy 38.83 15.01 58 11488 77617 64409569
Mental status changes 38.49 15.01 51 11495 61111 64426075
Lethargy 35.99 15.01 54 11492 72540 64414646
Respiratory rate decreased 35.69 15.01 17 11529 4474 64482712
Intestinal infarction 35.64 15.01 12 11534 1279 64485907
Pulmonary oedema 35.46 15.01 56 11490 78618 64408568
Brain oedema 34.79 15.01 30 11516 22045 64465141
Substance abuse 31.42 15.01 20 11526 9272 64477914
Drug dependence 31.18 15.01 34 11512 33278 64453908
Aplastic anaemia 30.63 15.01 23 11523 13897 64473289
Sinus tachycardia 30.39 15.01 33 11513 32155 64455031
Accidental exposure to product 30.23 15.01 30 11516 26334 64460852
Renal infarct 28.34 15.01 12 11534 2399 64484787
Abortion spontaneous 27.71 15.01 28 11518 25115 64462071
Generalised anxiety disorder 27.50 15.01 11 11535 1904 64485282
Withdrawal syndrome 27.43 15.01 27 11519 23465 64463721
Cerebral congestion 26.64 15.01 5 11541 45 64487141
Bradycardia 25.88 15.01 62 11484 118157 64369029
Respiratory acidosis 25.58 15.01 18 11528 9837 64477349
Hypoxic-ischaemic encephalopathy 23.20 15.01 15 11531 7137 64480049
Brief psychotic disorder with marked stressors 22.96 15.01 6 11540 265 64486921
Respiratory alkalosis 22.84 15.01 12 11534 3885 64483301
Apnoea 22.44 15.01 17 11529 10405 64476781
Drug abuse 22.37 15.01 63 11483 132311 64354875
Compartment syndrome 21.91 15.01 12 11534 4220 64482966
Agitation 21.14 15.01 48 11498 88319 64398867
Hypotension 20.94 15.01 128 11418 380846 64106340
Hypoaesthesia teeth 20.84 15.01 4 11542 41 64487145
Respiratory failure 20.08 15.01 69 11477 161114 64326072
Hypopnoea 19.19 15.01 10 11536 3184 64484002
Delirium 18.15 15.01 39 11507 69155 64418031
Electrocardiogram QT prolonged 17.74 15.01 42 11504 79406 64407780
Respiratory arrest 16.42 15.01 32 11514 52953 64434233
Pupil fixed 16.28 15.01 9 11537 3223 64483963
Restrictive cardiomyopathy 16.06 15.01 6 11540 865 64486321
Delayed recovery from anaesthesia 15.97 15.01 7 11539 1521 64485665
Rheumatoid arthritis 15.58 15.01 5 11541 164289 64322897
Hypercapnia 15.36 15.01 12 11534 7682 64479504
Axillary pain 15.13 15.01 7 11539 1725 64485461
Impaired insulin secretion 15.12 15.01 3 11543 37 64487149

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A06AH04 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Peripheral opioid receptor antagonists
ATC N02AA53 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA55 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AX51 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Other opioids
ATC V03AB15 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
FDA MoA N0000000154 Opioid Antagonists
MeSH PA D002491 Central Nervous System Agents
MeSH PA D009292 Narcotic Antagonists
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:50137 mu-opioid receptor antagonists
CHEBI has role CHEBI:90755 antidote to opioid overdose
FDA EPC N0000175691 Opioid Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Opioid dependence indication 75544000 DOID:2559
Poisoning by opiate analgesic drug indication 241749009
Prevention of opioid abuse indication 426928008
Opiate-Induced Respiratory Depression indication
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcohol withdrawal delirium contraindication 8635005
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Orthostatic hypotension contraindication 28651003
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Dehydration contraindication 34095006
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Bradycardia contraindication 48867003
Paralytic ileus contraindication 55525008 DOID:8442
Chronic type B viral hepatitis contraindication 61977001
Ulcerative colitis contraindication 64766004 DOID:8577
Substance abuse contraindication 66214007
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
Opioid withdrawal contraindication 87132004
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Acute abdominal pain contraindication 116290004
Neoplasm of brain contraindication 126952004 DOID:1319
Chronic hepatitis C contraindication 128302006
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Exacerbation of asthma contraindication 281239006
Lesion of brain contraindication 301766008
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Respiratory insufficiency contraindication 409623005
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Congenital long QT syndrome contraindication 442917000
Kyphoscoliosis with Respiratory Compromise contraindication
Pain in Opioid Naive Patients contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.31 acidic
pKa2 7.47 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
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
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9724471 May 23, 2027 METHOD FOR CONFIRMING DOSE DELIVERY
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9724471 May 23, 2027 METHOD FOR CONFIRMING DOSE DELIVERY
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 0.7MG 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
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10322239 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9474869 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10322239 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9474869 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML) NALOXONE HYDROCHLORIDE (AUTOINJECTOR) KALEO INC N215457 Feb. 28, 2022 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10322239 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML) NALOXONE HYDROCHLORIDE (AUTOINJECTOR) KALEO INC N215457 Feb. 28, 2022 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9474869 Feb. 28, 2031 USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10143972 May 24, 2031 USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10143792 May 24, 2031 USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML) NALOXONE HYDROCHLORIDE (AUTOINJECTOR) KALEO INC N215457 Feb. 28, 2022 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10143792 May 24, 2031 USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
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
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9517307 July 18, 2034 USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 9517307 July 18, 2034 USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL
8MG/SPRAY KLOXXADO HIKMA N212045 April 29, 2021 RX SPRAY NASAL 10722510 Aug. 26, 2034 USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
8MG/SPRAY KLOXXADO HIKMA N212045 April 29, 2021 RX SPRAY NASAL 10973814 Aug. 26, 2034 USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** NARCAN EMERGENT N208411 Jan. 24, 2017 DISCN SPRAY, METERED NASAL 9480644 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** NARCAN EMERGENT N208411 Jan. 24, 2017 DISCN SPRAY, METERED NASAL 9707226 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
4MG/SPRAY NARCAN EMERGENT N208411 Nov. 18, 2015 RX SPRAY, METERED NASAL 10085937 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
4MG/SPRAY NARCAN EMERGENT N208411 Nov. 18, 2015 RX SPRAY, METERED NASAL 9468747 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
4MG/SPRAY NARCAN EMERGENT N208411 Nov. 18, 2015 RX SPRAY, METERED NASAL 9561177 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
4MG/SPRAY NARCAN EMERGENT N208411 Nov. 18, 2015 RX SPRAY, METERED NASAL 9629965 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
4MG/SPRAY NARCAN EMERGENT N208411 Nov. 18, 2015 RX SPRAY, METERED NASAL 9775838 March 16, 2035 USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
0.4MG/0.4ML (0.4MG/0.4ML) EVZIO KALEO INC N205787 April 3, 2014 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10220158 March 20, 2035 USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE
2MG/0.4ML (2MG/0.4ML) EVZIO (AUTOINJECTOR) KALEO INC N209862 Oct. 19, 2016 DISCN SOLUTION INTRAMUSCULAR, SUBCUTANEOUS 10220158 March 20, 2035 USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
4MG/SPRAY NALOXONE HYDROCHLORIDE TEVA PHARMS USA A209522 April 19, 2019 RX SPRAY, METERED NASAL June 20, 2022 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR ANTAGONIST Ki 8.81 WOMBAT-PK CHEMBL
Cytochrome P450 2D6 Enzyme IC50 5.70 DRUG MATRIX
Adenosine receptor A3 GPCR IC50 8.80 CHEMBL
Kappa-type opioid receptor GPCR ANTAGONIST Ki 8.50 WOMBAT-PK
Delta-type opioid receptor GPCR ANTAGONIST Ki 7.27 WOMBAT-PK
Kappa-type opioid receptor GPCR Ki 8.50 CHEMBL
Mu-type opioid receptor GPCR Kd 9.40 CHEMBL
Mu-type opioid receptor GPCR ANTAGONIST Ki 9 IUPHAR
Mu-type opioid receptor GPCR Ki 9.17 CHEMBL
Delta-type opioid receptor GPCR Kd 7.30 CHEMBL
Kappa-type opioid receptor GPCR Kd 9 CHEMBL
Kappa-type opioid receptor GPCR ANTAGONIST IC50 8.30 IUPHAR
Mu-type opioid receptor GPCR IC50 8.30 CHEMBL
C-C chemokine receptor type 5 GPCR Kd 7.98 CHEMBL
Delta-type opioid receptor GPCR Kd 7.74 CHEMBL
Opioid receptor GPCR Kd 9 CHEMBL

External reference:

IDSource
D01340 KEGG_DRUG
357-08-4 SECONDARY_CAS_RN
4018057 VANDF
4019852 VANDF
C0027358 UMLSCUI
CHEBI:7459 CHEBI
CHEMBL80 ChEMBL_ID
CHEMBL1718 ChEMBL_ID
DB01183 DRUGBANK_ID
D009270 MESH_DESCRIPTOR_UI
5284596 PUBCHEM_CID
1638 IUPHAR_LIGAND_ID
1526 INN_ID
36B82AMQ7N UNII
1010598 RXNORM
2074 MMSL
221948 MMSL
27364 MMSL
5150 MMSL
71995 MMSL
d00311 MMSL
001614 NDDF
004661 NDDF
21518006 SNOMEDCT_US
371000220109 SNOMEDCT_US
372890007 SNOMEDCT_US
89018006 SNOMEDCT_US
51481-60-8 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 0.50 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 0.50 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 2 mg SUBLINGUAL ANDA 33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-2165 SPRAY, METERED 4 mg NASAL ANDA 23 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-2165 SPRAY, METERED 4 mg NASAL ANDA 23 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 0.50 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 0.50 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 2 mg SUBLINGUAL ANDA 33 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8765 FILM 0.50 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8766 FILM 1 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8767 FILM 2 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8768 FILM 3 mg SUBLINGUAL ANDA 34 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9920 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 13 sections
NALOXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9921 INJECTION 1 mg PARENTERAL ANDA 14 sections
NALOXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9922 INJECTION 1 mg PARENTERAL ANDA 18 sections
NALOXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9922 INJECTION 1 mg PARENTERAL ANDA 18 sections
NALOXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9923 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 14 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8005 TABLET 0.50 mg SUBLINGUAL ANDA 37 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8020 TABLET 2 mg SUBLINGUAL ANDA 37 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1212 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 21 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1215 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 21 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1219 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 21 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-1782 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR ANDA 13 sections
Pentazocine and naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0591-0395 TABLET 0.50 mg ORAL ANDA 28 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6132 INJECTION 0.40 mg INTRAMUSCULAR ANDA 23 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6205 INJECTION 1 mg INTRAMUSCULAR ANDA 24 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6260 INJECTION 0.40 mg INTRAMUSCULAR ANDA 23 sections
Naloxone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-7176 INHALANT 4 mg NASAL NDA authorized generic 25 sections