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

Stem definition	Drug id	CAS RN
	836	40431-64-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: focalin dexmethylphenidate Methyl D-phenidate d-threo-Methylphenidate dexmethylphenidate hydrochloride dexmethylphenidate HCl	A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. Molecular weight: 233.31 Formula: C14H19NO2 CLOGP: 2.56 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 38.33 ALOGS: -3.11 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

focalin
dexmethylphenidate
Methyl D-phenidate
d-threo-Methylphenidate
dexmethylphenidate hydrochloride
dexmethylphenidate HCl

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Molecular weight: 233.31
Formula: C14H19NO2
CLOGP: 2.56
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 38.33
ALOGS: -3.11
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	8 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	6.67 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	2.65 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.06 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.87 %	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Nov. 13, 2001	FDA	NOVARTIS

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
Claustrophobia	94.80	34.48	18	2127	1000	63485877
Product tampering	89.59	34.48	15	2130	403	63486474
Adulterated product	89.40	34.48	14	2131	244	63486633
Pulse abnormal	79.67	34.48	18	2127	2346	63484531
Somatic symptom disorder	77.56	34.48	18	2127	2642	63484235
Mood swings	68.32	34.48	25	2120	18223	63468654
Neurological symptom	63.69	34.48	18	2127	5765	63481112
Hyperreflexia	63.23	34.48	18	2127	5916	63480961
Brain injury	60.18	34.48	18	2127	7025	63479852
Disturbance in attention	59.62	34.48	28	2117	38161	63448716

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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 substitution issue	223.77	34.95	63	2294	10032	34944542
Abnormal behaviour	175.02	34.95	65	2292	24904	34929670
Drug ineffective	110.11	34.95	143	2214	456608	34497966
Anger	83.32	34.95	31	2326	11853	34942721
Aggression	80.17	34.95	43	2314	38921	34915653
Tic	64.94	34.95	17	2340	2041	34952533
Disturbance in attention	60.05	34.95	31	2326	25914	34928660
Irritability	58.58	34.95	30	2327	24660	34929914
Brugada syndrome	58.38	34.95	13	2344	788	34953786
Attention deficit hyperactivity disorder	56.70	34.95	16	2341	2543	34952031

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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
Product substitution issue	231.82	33.47	68	3263	20188	79720869
Abnormal behaviour	92.52	33.47	40	3291	36381	79704676
Claustrophobia	86.99	33.47	18	3313	1252	79739805
Product tampering	86.04	33.47	15	3316	413	79740644
Disturbance in attention	85.75	33.47	42	3289	50759	79690298
Adulterated product	84.59	33.47	14	3317	280	79740777
Anger	79.14	33.47	29	3302	17133	79723924
Somatic symptom disorder	74.58	33.47	18	3313	2519	79738538
Tic	71.67	33.47	18	3313	2968	79738089
Pulse abnormal	69.43	33.47	18	3313	3366	79737691

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06BA11	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
ATC	N06BA15	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
CHEBI has role	CHEBI:37962	adrenergic agents
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

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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
Gilles de la Tourette's syndrome	contraindication	5158005	DOID:11119
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Sinus tachycardia	contraindication	11092001
Bipolar disorder	contraindication	13746004	DOID:3312
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Feeling agitated	contraindication	24199005
Hypertensive disorder	contraindication	38341003	DOID:10763

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.68	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
EQ 10.4MG BASE;EQ 52.3MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10858341	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 10.4MG BASE;EQ 52.3MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10954213	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 5.2MG BASE;EQ 26.1MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10858341	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 5.2MG BASE;EQ 26.1MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10954213	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 7.8MG BASE;EQ 39.2MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10858341	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 7.8MG BASE;EQ 39.2MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	10954213	Dec. 9, 2037	TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 10.4MG BASE;EQ 52.3MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	May 7, 2026	NEW CHEMICAL ENTITY
EQ 5.2MG BASE;EQ 26.1MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	May 7, 2026	NEW CHEMICAL ENTITY
EQ 7.8MG BASE;EQ 39.2MG BASE	AZSTARYS	COMMAVE THERAP	N212994	May 7, 2021	RX	CAPSULE	ORAL	May 7, 2026	NEW CHEMICAL ENTITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR			WOMBAT-PK	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	Ki	7.80	CHEMBL	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	7.13	CHEMBL
Transporter	Transporter		Q9WTR4_RAT		Ki	6.57	CHEMBL
Dopamine receptor	GPCR		DRD1_RAT DRD3_RAT DRD5_RAT DRD4_RAT DRD2_RAT		IC50	7.08	CHEMBL

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External reference:

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ID	Source
009511	NDDF
009512	NDDF
110936	MMSL
154101	PUBCHEM_CID
16208	MMSL
19262-68-1	SECONDARY_CAS_RN
352372	RXNORM
385555005	SNOMEDCT_US
39360	MMSL
4021285	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0380	TABLET	2.50 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0380	TABLET	2.50 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0380	TABLET	2.50 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0380	TABLET	2.50 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0381	TABLET	5 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0381	TABLET	5 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0381	TABLET	5 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0381	TABLET	5 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0382	TABLET	10 mg	ORAL	NDA	33 sections
Focalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0382	TABLET	10 mg	ORAL	NDA	33 sections

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