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

Stem definition	Drug id	CAS RN
anorexics	195	300-62-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: amphetamine aspartate monohydrate benzadrine amphetamine adderall 1-Benzylethylamine phenedrine (+/-)-1-Phenyl-2-aminopropane amfetamine amphetamine sulfate amphetamine aspartate amphetamine adipate amphetamine resin complex	A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE. Molecular weight: 135.21 Formula: C9H13N CLOGP: 1.74 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 26.02 ALOGS: -1.89 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

amphetamine aspartate monohydrate
benzadrine
amphetamine
adderall
1-Benzylethylamine
phenedrine
(+/-)-1-Phenyl-2-aminopropane
amfetamine
amphetamine sulfate
amphetamine aspartate
amphetamine adipate
amphetamine resin complex

A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.

Molecular weight: 135.21
Formula: C9H13N
CLOGP: 1.74
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 26.02
ALOGS: -1.89
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O
15	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	0	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	30 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	40 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	7.40 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	6.10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	9.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.80 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	7.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Sept. 9, 1955	FDA	UCB INC

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
Toxicity to various agents	1034.27	20.13	515	6609	246735	63235163
Completed suicide	945.12	20.13	412	6712	145261	63336637
Drug abuse	892.44	20.13	326	6798	72192	63409706
Cardio-respiratory arrest	349.05	20.13	158	6966	59801	63422097
Respiratory arrest	265.29	20.13	109	7015	32536	63449362
Cardiac arrest	207.40	20.13	129	6995	92416	63389482
Poisoning	147.09	20.13	56	7068	13644	63468254
Overdose	112.01	20.13	97	7027	114981	63366917
Coronary artery dissection	92.12	20.13	21	7103	841	63481057
Renal infarct	71.67	20.13	19	7105	1428	63480470
Exposure via ingestion	66.80	20.13	21	7103	2888	63479010
Death	57.15	20.13	128	6996	374253	63107645
Suspected suicide	43.50	20.13	19	7105	6549	63475349
Intentional product misuse	41.18	20.13	42	7082	60875	63421023
Serotonin syndrome	40.24	20.13	30	7094	28652	63453246
Agitation	40.03	20.13	41	7083	59716	63422182
Intestinal infarction	39.03	20.13	11	7113	1039	63480859
Substance abuse	38.80	20.13	16	7108	4791	63477107
Accidental overdose	38.69	20.13	27	7097	23282	63458616
Miosis	38.33	20.13	18	7106	7335	63474563
Intentional overdose	34.40	20.13	42	7082	74110	63407788
Product substitution issue	32.47	20.13	21	7103	15975	63465923
Tachycardia	32.43	20.13	52	7072	118104	63363794
Mydriasis	27.53	20.13	17	7107	11939	63469959
Brain oedema	27.26	20.13	18	7106	14177	63467721
Anterograde amnesia	26.22	20.13	7	7117	540	63481358
Drug screen positive	25.68	20.13	11	7113	3618	63478280
Drug intolerance	24.37	20.13	3	7121	308658	63173240
Diarrhoea	24.05	20.13	27	7097	715339	62766559
Arteritis infective	22.37	20.13	4	7120	45	63481853
Brachial artery entrapment syndrome	21.30	20.13	4	7120	60	63481838
Hepatic necrosis	20.96	20.13	11	7113	5676	63476222
Respiratory depression	20.71	20.13	15	7109	13700	63468198
Somnolence	20.64	20.13	55	7069	178630	63303268
Unresponsive to stimuli	20.48	20.13	22	7102	33794	63448104

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
Drug abuse	1872.25	30.85	729	7095	98367	34850740
Toxicity to various agents	1864.95	30.85	891	6933	199471	34749636
Completed suicide	484.87	30.85	290	7534	97878	34851229
Respiratory arrest	308.36	30.85	142	7682	27901	34921206
Cardio-respiratory arrest	265.93	30.85	161	7663	55112	34893995
Cardiac arrest	214.79	30.85	175	7649	95984	34853123
Substance abuse	184.43	30.85	68	7756	7573	34941534
Poisoning	176.39	30.85	75	7749	12151	34936956
Myelopathy	157.57	30.85	46	7778	2451	34946656
Overdose	156.95	30.85	143	7681	90916	34858191
Intentional product misuse	134.35	30.85	98	7726	45513	34903594
Brain oedema	115.30	30.85	58	7766	13763	34935344
Decreased eye contact	110.63	30.85	25	7799	470	34948637
Oppositional defiant disorder	108.05	30.85	25	7799	524	34948583
Respiratory depression	98.21	30.85	55	7769	16190	34932917
Pulmonary oedema	96.43	30.85	82	7742	47447	34901660
Drug dependence	94.72	30.85	62	7762	24155	34924952
Bruxism	92.22	30.85	28	7796	1707	34947400
Rhabdomyolysis	83.57	30.85	89	7735	68074	34881033
Aggression	80.60	30.85	68	7756	38896	34910211
Homicidal ideation	76.41	30.85	27	7797	2655	34946452
Crying	65.25	30.85	30	7794	5832	34943275
Compartment syndrome	62.40	30.85	24	7800	2994	34946113
Quadriparesis	61.22	30.85	20	7804	1549	34947558
Internal injury	58.61	30.85	9	7815	13	34949094
Choreoathetosis	55.81	30.85	17	7807	1047	34948060
Exposure via ingestion	54.77	30.85	20	7804	2161	34946946
Serotonin syndrome	52.28	30.85	40	7784	19893	34929214
Dyskinesia	50.23	30.85	41	7783	22372	34926735
Trismus	48.60	30.85	19	7805	2476	34946631
Suicidal ideation	46.39	30.85	51	7773	40337	34908770
Accidental overdose	45.47	30.85	37	7787	20103	34929004
Spinal shock	44.59	30.85	8	7816	42	34949065
Coordination abnormal	43.79	30.85	25	7799	7619	34941488
Hyperkinesia	43.61	30.85	16	7808	1752	34947355
Drug interaction	41.83	30.85	128	7696	225818	34723289
Diarrhoea	41.16	30.85	18	7806	389894	34559213
Dyspnoea	38.82	30.85	18	7806	376764	34572343
Vertebral artery dissection	38.67	30.85	7	7817	39	34949068
Affect lability	38.35	30.85	18	7806	3665	34945442
Intentional overdose	38.25	30.85	48	7776	43626	34905481
Stress cardiomyopathy	37.72	30.85	15	7809	2044	34947063
Pulmonary congestion	36.92	30.85	28	7796	13737	34935370
Anaemia	35.64	30.85	5	7819	233330	34715777
Prescription drug used without a prescription	33.66	30.85	14	7810	2140	34946967
Psychomotor hyperactivity	33.65	30.85	23	7801	9599	34939508
Streptococcal infection	33.27	30.85	18	7806	4943	34944164
Asphyxia	32.96	30.85	20	7804	6815	34942292
Mood altered	32.74	30.85	22	7802	8930	34940177
Poor quality sleep	31.91	30.85	21	7803	8235	34940872
Irritability	31.55	30.85	33	7791	24657	34924450
Pyrexia	31.16	30.85	18	7806	332995	34616112

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
Toxicity to various agents	2775.57	21.38	1343	11728	420197	79311120
Drug abuse	2729.04	21.38	1011	12060	161680	79569637
Completed suicide	1358.77	21.38	701	12370	245066	79486251
Cardio-respiratory arrest	631.92	21.38	322	12749	108188	79623129
Respiratory arrest	594.19	21.38	254	12817	57296	79674021
Cardiac arrest	440.31	21.38	300	12771	171796	79559521
Poisoning	319.31	21.38	129	12942	25143	79706174
Overdose	254.53	21.38	223	12848	183983	79547334
Intentional product misuse	159.62	21.38	129	12942	95036	79636281
Substance abuse	151.25	21.38	59	13012	10467	79720850
Respiratory depression	123.62	21.38	69	13002	27561	79703756
Brain oedema	121.03	21.38	66	13005	25197	79706120
Exposure via ingestion	118.92	21.38	41	13030	5133	79726184
Oppositional defiant disorder	118.27	21.38	25	13046	472	79730845
Coronary artery dissection	107.40	21.38	27	13044	1117	79730200
Decreased eye contact	104.47	21.38	25	13046	840	79730477
Death	101.64	21.38	260	12811	566254	79165063
Accidental overdose	100.77	21.38	69	13002	39512	79691805
Serotonin syndrome	95.01	21.38	70	13001	44957	79686360
Drug dependence	94.27	21.38	67	13004	40702	79690615
Aggression	87.31	21.38	70	13001	50888	79680429
Pulmonary oedema	85.56	21.38	88	12983	88166	79643151
Bruxism	77.63	21.38	28	13043	3998	79727319
Homicidal ideation	74.07	21.38	26	13045	3431	79727886
Intentional overdose	64.36	21.38	83	12988	105877	79625440
Diarrhoea	61.64	21.38	34	13037	880455	78850862
Miosis	58.78	21.38	35	13036	15754	79715563
Renal infarct	52.95	21.38	19	13052	2672	79728645
Agitation	51.22	21.38	72	12999	99643	79631674
Pulmonary congestion	48.05	21.38	38	13033	27062	79704255
Rhabdomyolysis	47.91	21.38	71	13000	103060	79628257
Unresponsive to stimuli	47.60	21.38	52	13019	55736	79675581
Anaemia	47.42	21.38	8	13063	445007	79286310
Dyspnoea	46.94	21.38	43	13028	856982	78874335
Choreoathetosis	46.25	21.38	15	13056	1555	79729762
Internal injury	46.01	21.38	11	13060	368	79730949
Dyskinesia	45.83	21.38	46	13025	44727	79686590
Suicidal ideation	45.09	21.38	59	13012	76281	79655036
Suspected suicide	43.47	21.38	25	13046	10551	79720766
Amphetamines positive	41.90	21.38	10	13061	332	79730985
Hyperkinesia	41.69	21.38	16	13055	2713	79728604
Drug screen positive	41.05	21.38	20	13051	6043	79725274
Trismus	39.94	21.38	19	13052	5448	79725869
Prescription drug used without a prescription	38.66	21.38	17	13054	4068	79727249
Stress cardiomyopathy	37.06	21.38	23	13048	11143	79720174
Pneumonia	36.25	21.38	33	13038	660213	79071104
Pyrexia	36.00	21.38	35	13036	678674	79052643
Compartment syndrome	35.11	21.38	17	13054	5065	79726252
Irritability	34.48	21.38	38	13033	41106	79690211
Coordination abnormal	34.45	21.38	26	13045	17286	79714031
Affect lability	34.38	21.38	22	13049	11237	79720080
Mydriasis	34.01	21.38	26	13045	17617	79713700
Crying	33.91	21.38	29	13042	23014	79708303
Off label use	33.64	21.38	61	13010	907154	78824163
Drug interaction	32.97	21.38	145	12926	415038	79316279
Psychomotor hyperactivity	32.86	21.38	25	13046	16824	79714493
Intestinal infarction	32.31	21.38	11	13060	1325	79729992
Streptococcal infection	31.38	21.38	19	13052	8811	79722506
Asphyxia	31.16	21.38	21	13050	11699	79719618
Product substitution issue	30.85	21.38	26	13045	20230	79711087
Drug intolerance	29.83	21.38	4	13067	264115	79467202
Rash	29.31	21.38	31	13040	578327	79152990
Vertebral artery dissection	29.11	21.38	7	13064	240	79731077
Cluster headache	27.25	21.38	9	13062	987	79730330
Drug use disorder	26.66	21.38	17	13054	8634	79722683
Mood altered	25.33	21.38	22	13049	17825	79713492
Pruritus	25.06	21.38	17	13054	394631	79336686
Abnormal behaviour	24.43	21.38	30	13041	36391	79694926
Substance use disorder	23.77	21.38	8	13063	930	79730387
Joint swelling	23.43	21.38	9	13062	288637	79442680
Arthralgia	23.41	21.38	36	13035	571767	79159550
Tachycardia	23.26	21.38	73	12998	177695	79553622
Malaise	22.90	21.38	28	13043	489841	79241476
Withdrawal syndrome	22.84	21.38	25	13046	26829	79704488
Accidental death	22.75	21.38	12	13059	4279	79727038
Thrombocytopenia	21.99	21.38	8	13063	265251	79466066
Physical abuse	21.76	21.38	4	13067	35	79731282

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N06BA01	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:48560	dopaminergic agents
CHEBI has role	CHEBI:50910	agente neurotoxico
CHEBI has role	CHEBI:51039	dopamine reuptake inhibitor
CHEBI has role	CHEBI:78298	environmental contaminants
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D000697	Central Nervous System Stimulants
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D018759	Adrenergic Uptake Inhibitors
MeSH PA	D015259	Dopamine Agents
MeSH PA	D018765	Dopamine Uptake Inhibitors
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D013566	Sympathomimetics
FDA PE	N0000175729	Central Nervous System Stimulation
FDA EPC	N0000175739	Central Nervous System Stimulant

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Narcolepsy	indication	60380001	DOID:8986
Attention deficit hyperactivity disorder	indication	406506008
Obesity	indication	414916001	DOID:9970
Ocular hypertension	contraindication	4210003	DOID:9282
Gilles de la Tourette's syndrome	contraindication	5158005	DOID:11119
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Hyperammonemia	contraindication	9360008
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Bipolar disorder	contraindication	13746004	DOID:3312
Hepatic encephalopathy	contraindication	13920009	DOID:13413
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Hyperthyroidism	contraindication	34486009	DOID:7998
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Hyperactive behavior	contraindication	44548000
Conduction disorder of the heart	contraindication	44808001
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Anorexia nervosa	contraindication	56882008	DOID:8689
Hepatic failure	contraindication	59927004
Aggressive behavior	contraindication	61372001
Substance abuse	contraindication	66214007
Psychotic disorder	contraindication	69322001
Arteriosclerotic vascular disease	contraindication	72092001
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Open-angle glaucoma	contraindication	84494001	DOID:1067
Cardiomyopathy	contraindication	85898001	DOID:0050700
Weight loss	contraindication	89362005
Kidney disease	contraindication	90708001	DOID:557
Structural disorder of heart	contraindication	128599005
Seizure disorder	contraindication	128613002
Motor tic disorder	contraindication	230337001
Cerebrovascular accident	contraindication	230690007
Mania	contraindication	231494001
Disease of liver	contraindication	235856003	DOID:409
Sleep automatism	contraindication	247962006
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Cardiovascular event risk	contraindication	395112001
Visual impairment	contraindication	397540003
Respiratory insufficiency	contraindication	409623005
Breastfeeding (mother)	contraindication	413712001
Disorder of coronary artery	contraindication	414024009
Myocardial ischemia	contraindication	414795007	DOID:3393
Myocardial infarction in recovery phase	contraindication	418044006
Porphyria	contraindication	418470004
Hypertensive urgency	contraindication	443482000
Acute exacerbation of asthma	contraindication	708038006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.89	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
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
9.375MG;9.375MG;9.375MG;9.375MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	6913768	May 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
9.375MG;9.375MG;9.375MG;9.375MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	9173857	May 12, 2026	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
2MG/ML;EQ 0.5MG BASE/ML	DYANAVEL XR	TRIS PHARMA INC	N208147	Oct. 19, 2015	RX	SUSPENSION, EXTENDED RELEASE	ORAL	11590228	Sept. 7, 2036	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
12MG;EQ 3MG BASE	DYANAVEL XR 15	TRIS PHARMA INC	N210526	Nov. 4, 2021	RX	TABLET, EXTENDED RELEASE	ORAL	11590081	Sept. 24, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
16MG;EQ 4MG BASE	DYANAVEL XR 20	TRIS PHARMA INC	N210526	Nov. 4, 2021	RX	TABLET, EXTENDED RELEASE	ORAL	11590081	Sept. 24, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
4MG;EQ 1MG BASE	DYANAVEL XR 5	TRIS PHARMA INC	N210526	Nov. 4, 2021	RX	TABLET, EXTENDED RELEASE	ORAL	11590081	Sept. 24, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
8MG;EQ 2MG BASE	DYANAVEL XR 10	TRIS PHARMA INC	N210526	Nov. 4, 2021	RX	TABLET, EXTENDED RELEASE	ORAL	11590081	Sept. 24, 2038	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
12.5MG;12.5MG;12.5MG;12.5MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
3.125MG;3.125MG;3.125MG;3.125MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
6.25MG;6.25MG;6.25MG;6.25MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY
9.375MG;9.375MG;9.375MG;9.375MG	MYDAYIS	TAKEDA PHARMS USA	N022063	June 20, 2017	RX	CAPSULE, EXTENDED RELEASE	ORAL	March 13, 2023	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	RELEASING AGENT	Ki	6.94	PDSP	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	RELEASING AGENT			CHEMBL	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN				WOMBAT-PK
Cocaine- and amphetamine-regulated transcript protein	Transcription factor	Q16568	CART_HUMAN				WOMBAT-PK
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN				WOMBAT-PK
Trace amine-associated receptor 1	GPCR	Q96RJ0	TAAR1_HUMAN	AGONIST	EC50	6.22	SCIENTIFIC LITERATURE
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	5.75	PDSP
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		IC50	6.02	CHEMBL
Amine oxidase [flavin-containing] A	Enzyme		AOFA_RAT		Ki	4.91	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter		SC6A2_MOUSE		IC50	6	CHEMBL
5-hydroxytryptamine receptor 2B	GPCR		5HT2B_RAT		Kd	5.27	CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_MOUSE		IC50	4.35	CHEMBL
Transporter	Transporter		Q63380_RAT		IC50	6.70	CHEMBL
Serotonin (5-HT) receptor	GPCR		5HT2C_RAT 5HT2A_RAT 5HT1A_RAT 5HT1B_RAT 5HT1D_RAT 5HT1F_RAT 5HT2B_RAT 5HT6R_RAT 5HT7R_RAT 5HT5A_RAT 5HT5B_RAT 5HT3A_RAT 5HT4R_RAT 5HT3B_RAT		Kd	5.27	CHEMBL
Serotonin 1 (5-HT1) receptor	GPCR		5HT1A_RAT 5HT1B_RAT 5HT1D_RAT 5HT1F_RAT		Ki	5.12	CHEMBL
Serotonin 2 (5-HT2) receptor	GPCR		5HT2C_RAT 5HT2A_RAT 5HT2B_RAT		Ki	4.37	CHEMBL

External reference:

ID	Source
4019611	VUID
N0000147705	NUI
D02074	KEGG_DRUG
851591-76-9	SECONDARY_CAS_RN
60-13-9	SECONDARY_CAS_RN
25333-81-7	SECONDARY_CAS_RN
221057	RXNORM
C0002658	UMLSCUI
CHEBI:2679	CHEBI
CHEMBL405	ChEMBL_ID
CHEMBL501	ChEMBL_ID
CHEMBL1200377	ChEMBL_ID
DB00182	DRUGBANK_ID
C090411	MESH_SUPPLEMENTAL_RECORD_UI
4804	IUPHAR_LIGAND_ID
64770-51-0	SECONDARY_CAS_RN
3007	PUBCHEM_CID
290726	MMSL
31375	MMSL
4188	MMSL
4189	MMSL
6025	MMSL
d00803	MMSL
116344009	SNOMEDCT_US
22672005	SNOMEDCT_US
703842006	SNOMEDCT_US
87148003	SNOMEDCT_US
D000661	MESH_DESCRIPTOR_UI
CHEMBL1200387	ChEMBL_ID
377	INN_ID
4018832	VANDF
4018833	VANDF
4018834	VANDF
4019611	VANDF
4022215	VANDF
O1ZPV620O4	UNII
001790	NDDF
001791	NDDF
001792	NDDF
006719	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1328	CAPSULE, EXTENDED RELEASE	1.25 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1328	CAPSULE, EXTENDED RELEASE	1.25 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1329	CAPSULE, EXTENDED RELEASE	2.50 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1329	CAPSULE, EXTENDED RELEASE	2.50 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1330	CAPSULE, EXTENDED RELEASE	3.75 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1330	CAPSULE, EXTENDED RELEASE	3.75 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1331	CAPSULE, EXTENDED RELEASE	5 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1331	CAPSULE, EXTENDED RELEASE	5 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1332	CAPSULE, EXTENDED RELEASE	6.25 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1332	CAPSULE, EXTENDED RELEASE	6.25 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1333	CAPSULE, EXTENDED RELEASE	7.50 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1333	CAPSULE, EXTENDED RELEASE	7.50 mg	ORAL	NDA AUTHORIZED GENERIC	36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1486	CAPSULE	1.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1487	CAPSULE	2.50 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1488	CAPSULE	3.75 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1489	CAPSULE	5 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1489	CAPSULE	5 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1489	CAPSULE	5 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1489	CAPSULE	5 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1490	CAPSULE	6.25 mg	ORAL	ANDA	28 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	4	0115-1490	CAPSULE	6.25 mg	ORAL	ANDA	28 sections