tapentadol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
analgesics 4283 175591-09-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tapentadol
  • tapentadol hydrochloride
  • nucynta
  • tapentadol HCl
An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.
  • Molecular weight: 221.34
  • Formula: C14H23NO
  • CLOGP: 3.15
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 23.47
  • ALOGS: -2.45
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 4.64 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 21.33 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.39 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 2008 FDA JANSSEN PHARMS

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 interaction 117.75 15.68 165 9347 199456 50396156
Sopor 104.94 15.68 58 9454 19821 50575791
Serotonin syndrome 103.48 15.68 62 9450 24651 50570961
Toxicity to various agents 95.82 15.68 155 9357 212344 50383268
Drug abuse 58.67 15.68 64 9448 59782 50535830
Confusional state 54.88 15.68 113 9399 185815 50409797
Delirium 54.32 15.68 50 9462 38142 50557470
Overdose 53.58 15.68 79 9433 99648 50495964
Respiratory depression 52.51 15.68 31 9481 11979 50583633
Agitation 50.43 15.68 56 9456 53328 50542284
Intentional overdose 49.71 15.68 60 9452 62444 50533168
Somnolence 47.85 15.68 96 9416 154889 50440723
Eyelid skin dryness 42.43 15.68 8 9504 70 50595542
Restlessness 41.84 15.68 36 9476 25137 50570475
Suicide attempt 41.68 15.68 50 9462 51682 50543930
Completed suicide 41.06 15.68 82 9430 131807 50463805
Sepsis neonatal 38.27 15.68 10 9502 420 50595192
Unresponsive to stimuli 37.67 15.68 37 9475 30572 50565040
Embolism venous 37.29 15.68 15 9497 2510 50593102
Reflexes abnormal 35.88 15.68 10 9502 537 50595075
Loss of consciousness 35.04 15.68 67 9445 104286 50491326
Hallucination 34.20 15.68 43 9469 46614 50548998
Accidental exposure to product by child 33.53 15.68 11 9501 1029 50594583
Suicidal ideation 32.83 15.68 46 9466 55339 50540273
Mydriasis 32.80 15.68 22 9490 10605 50585007
Miosis 32.16 15.68 18 9494 6292 50589320
Tremor 31.70 15.68 68 9444 114835 50480777
Amnestic disorder 31.21 15.68 8 9504 311 50595301
Depressed level of consciousness 30.57 15.68 43 9469 51910 50543702
Chemical burn of oral cavity 30.50 15.68 6 9506 67 50595545
Renal cell carcinoma stage I 30.49 15.68 5 9507 17 50595595
Disorientation 29.73 15.68 35 9477 35449 50560163
Allodynia 29.27 15.68 9 9503 683 50594929
Application site injury 28.78 15.68 5 9507 26 50595586
Drug withdrawal syndrome neonatal 27.40 15.68 11 9501 1830 50593782
Hypertensive crisis 26.42 15.68 21 9491 13133 50582479
Abdominal discomfort 23.82 15.68 7 9505 231634 50363978
Gaze palsy 23.49 15.68 9 9503 1324 50594288
Malignant neoplasm progression 23.17 15.68 44 9468 68080 50527532
Synovial disorder 23.02 15.68 8 9504 892 50594720
Seizure 23.01 15.68 61 9451 117813 50477799
Application site ulcer 22.84 15.68 5 9507 97 50595515
Opiates negative 22.74 15.68 3 9509 0 50595612
Myoclonic epilepsy 22.40 15.68 8 9504 967 50594645
Radiculopathy 22.24 15.68 13 9499 4928 50590684
Bradyphrenia 22.08 15.68 14 9498 6138 50589474
Lymphoedema 21.46 15.68 16 9496 9106 50586506
Adverse event 21.10 15.68 33 9479 43730 50551882
Bacteriuria 20.94 15.68 7 9505 694 50594918
Drug screen positive 20.94 15.68 11 9501 3391 50592221
Tachycardia 20.88 15.68 53 9459 99710 50495902
Concomitant disease aggravated 20.86 15.68 15 9497 8076 50587536
Urinary retention 20.57 15.68 25 9487 26165 50569447
Sedation 20.52 15.68 27 9485 30583 50565029
Hyperresponsive to stimuli 20.47 15.68 4 9508 43 50595569
Hyperhidrosis 20.29 15.68 49 9463 89377 50506235
Synovectomy 20.04 15.68 5 9507 174 50595438
Pharyngeal enanthema 19.63 15.68 4 9508 54 50595558
Aortic valve stenosis 19.40 15.68 10 9502 2965 50592647
Withdrawal syndrome 19.32 15.68 20 9492 17570 50578042
Thoracic vertebral fracture 19.09 15.68 11 9501 4062 50591550
Logorrhoea 18.67 15.68 9 9503 2315 50593297
Product prescribing error 18.10 15.68 21 9491 20940 50574672
Drug screen negative 18.00 15.68 5 9507 265 50595347
Stenosis 17.37 15.68 7 9505 1176 50594436
Constipation 17.35 15.68 75 9437 185633 50409979
Systemic lupus erythematosus 16.93 15.68 3 9509 140619 50454993
Total bile acids increased 16.30 15.68 4 9508 130 50595482
Drug screen false positive 16.13 15.68 6 9506 813 50594799
Disturbance in attention 15.71 15.68 24 9488 31162 50564450

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
Delirium 111.98 19.38 78 5602 39319 29529528
Serotonin syndrome 102.29 19.38 55 5625 17457 29551390
Quality of life decreased 75.30 19.38 27 5653 3235 29565612
Drug abuse 71.18 19.38 82 5598 79801 29489046
Hyperaesthesia 69.99 19.38 26 5654 3443 29565404
Constipation 69.67 19.38 97 5583 114063 29454784
Suicide attempt 62.46 19.38 52 5628 34058 29534789
Overdose 56.55 19.38 73 5607 79746 29489101
Toxicity to various agents 52.75 19.38 108 5572 173553 29395294
Sopor 49.30 19.38 29 5651 10905 29557942
Intentional overdose 41.96 19.38 44 5636 38484 29530363
Confusional state 39.31 19.38 80 5600 127797 29441050
Respiratory depression 34.25 19.38 25 5655 13498 29555349
Hallucination 33.36 19.38 42 5638 44670 29524177
Application site hypersensitivity 32.76 19.38 7 5673 118 29568729
Adverse event 31.52 19.38 25 5655 15266 29553581
Drug dependence 30.36 19.38 28 5652 20953 29547894
Xanthelasma 28.43 19.38 6 5674 95 29568752
Somnolence 27.91 19.38 58 5622 93897 29474950
Polyneuropathy in malignant disease 27.55 19.38 6 5674 111 29568736
Drug screen positive 25.18 19.38 13 5667 3788 29565059
Malignant neoplasm progression 24.80 19.38 48 5632 73811 29495036
Drug interaction 24.24 19.38 88 5592 197297 29371550
Accidental exposure to product by child 23.16 19.38 9 5671 1345 29567502
Withdrawal syndrome 22.71 19.38 18 5662 10974 29557873
Post herpetic neuralgia 22.38 19.38 8 5672 948 29567899
Myofascial pain syndrome 21.74 19.38 6 5674 304 29568543
Burns second degree 20.85 19.38 6 5674 354 29568493
Tobacco abuse 20.32 19.38 6 5674 388 29568459
Physical deconditioning 20.06 19.38 7 5673 774 29568073
Sleep deficit 19.61 19.38 6 5674 438 29568409

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
Delirium 140.60 15.80 113 12520 69081 64417018
Sopor 138.47 15.80 81 12552 29580 64456519
Toxicity to various agents 137.75 15.80 251 12382 363262 64122837
Serotonin syndrome 115.23 15.80 80 12553 39202 64446897
Drug abuse 114.15 15.80 135 12498 132239 64353860
Drug interaction 103.16 15.80 222 12411 361861 64124238
Suicide attempt 90.33 15.80 89 12544 70918 64415181
Intentional overdose 88.05 15.80 98 12535 89846 64396253
Respiratory depression 83.79 15.80 54 12579 23389 64462710
Accidental exposure to product by child 77.95 15.80 26 12607 2459 64483640
Overdose 77.11 15.80 123 12510 159443 64326656
Confusional state 75.24 15.80 161 12472 260983 64225116
Somnolence 66.20 15.80 132 12501 203513 64282586
Hyperaesthesia 64.99 15.80 34 12599 9980 64476119
Constipation 57.69 15.80 134 12499 229203 64256896
Restlessness 52.68 15.80 51 12582 39734 64446365
Quality of life decreased 52.08 15.80 27 12606 7779 64478320
Allodynia 46.60 15.80 15 12618 1268 64484831
Sepsis neonatal 45.66 15.80 8 12625 42 64486057
Loss of consciousness 45.58 15.80 94 12539 148271 64337828
Agitation 43.84 15.80 69 12564 88298 64397801
Malignant neoplasm progression 42.57 15.80 78 12555 112793 64373306
Eyelid skin dryness 40.79 15.80 8 12625 84 64486015
Disorientation 38.53 15.80 51 12582 55777 64430322
Drug screen positive 35.89 15.80 19 12614 5710 64480389
Tremor 33.33 15.80 83 12550 148147 64337952
Unresponsive to stimuli 33.19 15.80 45 12588 50348 64435751
Drug withdrawal syndrome neonatal 32.76 15.80 8 12625 244 64485855
Miosis 31.97 15.80 24 12609 13242 64472857
Depressed level of consciousness 31.61 15.80 57 12576 81379 64404720
Reflexes abnormal 31.60 15.80 10 12623 800 64485299
Completed suicide 31.42 15.80 106 12527 224308 64261791
Hallucination 30.91 15.80 53 12580 72735 64413364
Application site injury 29.27 15.80 5 12628 22 64486077
Sedation 28.80 15.80 38 12595 41424 64444675
Renal cell carcinoma stage I 26.60 15.80 5 12628 41 64486058
Amnestic disorder 26.44 15.80 8 12625 551 64485548
Disturbance in attention 26.02 15.80 36 12597 41038 64445061
Polyneuropathy in malignant disease 25.56 15.80 6 12627 154 64485945
Xanthelasma 25.34 15.80 6 12627 160 64485939
Chemical burn of oral cavity 24.37 15.80 5 12628 67 64486032
False positive investigation result 23.61 15.80 8 12625 793 64485306
Hypertensive crisis 23.41 15.80 23 12610 18225 64467874
Substance abuse 22.81 15.80 17 12616 9275 64476824
Pneumonia aspiration 22.38 15.80 41 12592 59230 64426869
Synovial disorder 22.29 15.80 8 12625 940 64485159
Application site ulcer 21.83 15.80 5 12628 115 64485984
Mydriasis 20.96 15.80 20 12613 15292 64470807
Bradyphrenia 20.44 15.80 16 12617 9390 64476709
Hyperresponsive to stimuli 20.31 15.80 4 12629 43 64486056
Embolism venous 20.20 15.80 11 12622 3496 64482603
Thoracic vertebral fracture 20.09 15.80 12 12621 4541 64481558
Radiculopathy 20.08 15.80 13 12620 5665 64480434
Haemoglobin decreased 19.37 15.80 7 12626 195056 64291043
Drug dependence 19.33 15.80 28 12605 33284 64452815
Hyperhidrosis 19.25 15.80 61 12572 124859 64361240
Pharyngeal enanthema 19.20 15.80 4 12629 58 64486041
Benign prostatic hyperplasia 18.65 15.80 15 12618 9150 64476949
Bacteriuria 18.64 15.80 7 12626 935 64485164
Hallucination, visual 18.54 15.80 25 12608 27809 64458290
Synovectomy 18.51 15.80 5 12628 229 64485870
Seizure 18.40 15.80 73 12560 166819 64319280
Myoclonic epilepsy 18.20 15.80 8 12625 1600 64484499
Psychomotor hyperactivity 18.14 15.80 18 12615 14433 64471666
Suicidal ideation 17.92 15.80 40 12593 66502 64419597
Gaze palsy 17.53 15.80 9 12624 2541 64483558
Urinary retention 17.28 15.80 33 12600 49168 64436931
Physical deconditioning 17.15 15.80 7 12626 1166 64484933
Application site reaction 16.69 15.80 6 12627 709 64485390

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AX06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Other opioids
FDA MoA N0000000174 Opioid Agonists
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake Inhibitors
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 D049990 Membrane Transport Modulators
MeSH PA D009294 Narcotics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175690 Opioid Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Alcohol intoxication contraindication 25702006
Hypercapnia contraindication 29596007
Myxedema contraindication 43153006 DOID:11634
Paralytic ileus contraindication 55525008 DOID:8442
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Sleep apnea contraindication 73430006 DOID:0050847
Pancreatitis contraindication 75694006 DOID:4989
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Disorder of biliary tract contraindication 105997008 DOID:9741
Seizure disorder contraindication 128613002
Disease of liver contraindication 235856003 DOID:409
Morbid obesity contraindication 238136002 DOID:11981
Exacerbation of asthma contraindication 281239006
Lesion of brain contraindication 301766008
Coma contraindication 371632003
Hypoxia contraindication 389086002
Central nervous system depression contraindication 418072004
Acute exacerbation of asthma contraindication 708038006
Kyphoscoliosis with Respiratory Compromise contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.76 acidic
pKa2 9.12 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 100MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 50MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 75MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL RE39593 Aug. 5, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 20MG BASE/ML NUCYNTA COLLEGIUM PHARM INC N203794 Oct. 15, 2012 DISCN SOLUTION ORAL RE39593 Aug. 5, 2022 MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 11007156 Oct. 22, 2022 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8309060 Nov. 20, 2023 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 100MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 50MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 75MG BASE NUCYNTA COLLEGIUM PHARM INC N022304 Nov. 20, 2008 RX TABLET ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 7994364 June 27, 2025 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
EQ 20MG BASE/ML NUCYNTA COLLEGIUM PHARM INC N203794 Oct. 15, 2012 DISCN SOLUTION ORAL 7994364 June 27, 2025 MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
EQ 100MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8536130 Sept. 22, 2028 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 150MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8536130 Sept. 22, 2028 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 200MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8536130 Sept. 22, 2028 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 250MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8536130 Sept. 22, 2028 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
EQ 50MG BASE NUCYNTA ER COLLEGIUM PHARM INC N200533 Aug. 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8536130 Sept. 22, 2028 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 7.02 WOMBAT-PK CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 6.32 WOMBAT-PK CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.66 CHEMBL

External reference:

IDSource
4029061 VUID
N0000179820 NUI
D06007 KEGG_DRUG
4029061 VANDF
4029062 VANDF
C2001271 UMLSCUI
CHEBI:135935 CHEBI
CHEMBL1201776 ChEMBL_ID
CHEMBL1201777 ChEMBL_ID
D000077432 MESH_DESCRIPTOR_UI
DB06204 DRUGBANK_ID
7477 IUPHAR_LIGAND_ID
8216 INN_ID
H8A007M585 UNII
9838022 PUBCHEM_CID
787390 RXNORM
165888 MMSL
26545 MMSL
35753 MMSL
d07453 MMSL
013168 NDDF
013169 NDDF
441757005 SNOMEDCT_US
442004000 SNOMEDCT_US
442699004 SNOMEDCT_US
175591-23-8 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NUCYNTA HUMAN PRESCRIPTION DRUG LABEL 1 16590-289 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
NUCYNTA HUMAN PRESCRIPTION DRUG LABEL 1 16590-863 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
NUCYNTA HUMAN PRESCRIPTION DRUG LABEL 1 16590-889 TABLET, FILM COATED 75 mg ORAL NDA 32 sections
NUCYNTA HUMAN PRESCRIPTION DRUG LABEL 1 21695-069 TABLET, FILM COATED 50 mg ORAL NDA 34 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 24510-050 TABLET, FILM COATED 50 mg ORAL NDA 37 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-058 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-058 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 38 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 24510-075 TABLET, FILM COATED 75 mg ORAL NDA 37 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 24510-100 TABLET, FILM COATED 100 mg ORAL NDA 37 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-116 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-116 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-174 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-174 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-232 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-232 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-291 TABLET, FILM COATED, EXTENDED RELEASE 250 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 24510-291 TABLET, FILM COATED, EXTENDED RELEASE 250 mg ORAL NDA 38 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 54868-5979 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 54868-6002 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 54868-6039 TABLET, FILM COATED 100 mg ORAL NDA 33 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 55700-792 TABLET, FILM COATED 50 mg ORAL NDA 37 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 55700-796 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 38 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 55700-797 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 38 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 69865-210 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 69865-220 TABLET, FILM COATED 75 mg ORAL NDA 35 sections
Nucynta HUMAN PRESCRIPTION DRUG LABEL 1 69865-230 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 69865-240 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 34 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 69865-245 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 34 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 69865-250 TABLET, FILM COATED, EXTENDED RELEASE 150 mg ORAL NDA 34 sections
NucyntaER HUMAN PRESCRIPTION DRUG LABEL 1 69865-260 TABLET, FILM COATED, EXTENDED RELEASE 200 mg ORAL NDA 34 sections