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

Stem definition	Drug id	CAS RN
analgesics	4283	175591-09-0

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.40	g	O

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
Nov. 20, 2008	FDA	JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	9.76	acidic
pKa2	9.12	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	7.02	WOMBAT-PK	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	6.32	WOMBAT-PK	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.66	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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