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

Stem definition	Drug id	CAS RN
anorexics	4135	608137-32-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lisdexamfetamine lisdexamphetamine lisdexamfetamine dimesylate vyvanse lisdexamfetamine mesilate	A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. Molecular weight: 263.39 Formula: C15H25N3O CLOGP: 0.81 LIPINSKI: 0 HAC: 4 HDO: 3 TPSA: 81.14 ALOGS: -3.48 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lisdexamfetamine
lisdexamphetamine
lisdexamfetamine dimesylate
vyvanse
lisdexamfetamine mesilate

A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Molecular weight: 263.39
Formula: C15H25N3O
CLOGP: 0.81
LIPINSKI: 0
HAC: 4
HDO: 3
TPSA: 81.14
ALOGS: -3.48
ROTB: 8

Status: OFP

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

Drug dosage:

Dose	Unit	Route
30	mg	O

ADMET properties:

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Property	Value	Reference
CL (Clearance)	17 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.20 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.60 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Feb. 23, 2007	FDA	SHIRE DEVELOPMENT
March 26, 2019	PMDA	SHIONOGI & CO., LTD.

FDA Adverse Event Reporting System (Female)

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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
Intentional self-injury	884.02	17.13	318	18201	25369	63445134
Product quality issue	763.68	17.13	313	18206	35552	63434951
Intentional overdose	696.97	17.13	367	18152	73785	63396718
Disturbance in attention	395.48	17.13	202	18317	37987	63432516
Product physical issue	393.91	17.13	116	18403	4864	63465639
No adverse event	193.75	17.13	131	18388	41274	63429229
Inappropriate schedule of product administration	180.52	17.13	185	18334	103780	63366723
Feeling abnormal	173.70	17.13	215	18304	148177	63322326
Drug ineffective	151.97	17.13	652	17867	1044113	62426390
Wrong technique in product usage process	148.19	17.13	132	18387	62208	63408295

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FDA Adverse Event Reporting System (Male)

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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
Product quality issue	774.44	25.35	273	12210	16762	34927686
Product physical issue	371.54	25.35	100	12383	2441	34942007
Intentional self-injury	314.46	25.35	134	12349	13637	34930811
Tic	286.82	25.35	78	12405	1980	34942468
Aggression	280.50	25.35	174	12309	38790	34905658
Disturbance in attention	274.93	25.35	149	12334	25796	34918652
Psychomotor hyperactivity	227.46	25.35	96	12387	9526	34934922
Drug ineffective	224.43	25.35	497	11986	456254	34488194
No adverse event	205.51	25.35	118	12365	22809	34921639
Therapeutic product effect decreased	205.07	25.35	137	12346	34606	34909842

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FDA Adverse Event Reporting System (Geriatric)

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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
Intentional self-injury	973.70	18.14	359	21930	32060	79690039
Product quality issue	924.93	18.14	350	21939	33590	79688509
Intentional overdose	681.84	18.14	403	21886	105557	79616542
Disturbance in attention	411.86	18.14	225	22064	50576	79671523
Tic	318.27	18.14	87	22202	2899	79719200
Product physical issue	293.55	18.14	88	22201	4097	79718002
Aggression	291.47	18.14	180	22109	50778	79671321
Suicidal ideation	258.46	18.14	195	22094	76145	79645954
Irritability	229.32	18.14	143	22146	41001	79681098
Psychomotor hyperactivity	207.42	18.14	99	22190	16750	79705349

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06BA12	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
FDA EPC	N0000175739	Central Nervous System Stimulant
FDA PE	N0000175729	Central Nervous System Stimulation
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D000697	Central Nervous System Stimulants
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

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

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Disease	Relation	SNOMED_ID	DOID
Attention deficit hyperactivity disorder	indication	406506008
Binge eating disorder	indication	439960005
Narcolepsy	off-label use	60380001	DOID:8986
Gilles de la Tourette's syndrome	contraindication	5158005	DOID:11119
Bipolar disorder	contraindication	13746004	DOID:3312
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.84	acidic
pKa2	10.65	Basic
pKa3	7.51	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7659253	Feb. 24, 2023	FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7659254	Feb. 24, 2023	TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7662788	Feb. 24, 2023	FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7671030	Feb. 24, 2023	FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7671031	Feb. 24, 2023	FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7674774	Feb. 24, 2023	INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7678770	Feb. 24, 2023	INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7687467	Feb. 24, 2023	INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7713936	Feb. 24, 2023	FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG	VYVANSE	TAKEDA PHARMS USA	N021977	Oct. 30, 2014	RX	CAPSULE	ORAL	7718619	Feb. 24, 2023	INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	RELEASING AGENT	CHEMBL	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	RELEASING AGENT	DRUGBANK	CHEMBL
Synaptic vesicular amine transporter	Transporter	Q05940	VMAT2_HUMAN	INHIBITOR	CHEMBL	CHEMBL

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External reference:

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ID	Source
011972	NDDF
011987	NDDF
108098	MMSL
11597698	PUBCHEM_CID
23471	MMSL
4026030	VUID
4026030	VANDF
4026031	VANDF
425597005	SNOMEDCT_US
426249000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0370	CAPSULE	20 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0371	CAPSULE	30 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0372	CAPSULE	40 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0373	CAPSULE	50 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0374	CAPSULE	60 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0375	CAPSULE	70 mg	ORAL	ANDA	28 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6854	CAPSULE	10 mg	ORAL	ANDA	33 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6855	CAPSULE	20 mg	ORAL	ANDA	33 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6856	CAPSULE	30 mg	ORAL	ANDA	33 sections
Lisdexamfetamine Dimesylate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-6857	CAPSULE	40 mg	ORAL	ANDA	33 sections

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