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

Stem definition	Drug id	CAS RN
	1767	113-45-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: methylphenidate calocain methylphenidan phenidylate methylphenidate hydrochloride concerta methylphenidate HCl	A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE. 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:

methylphenidate
calocain
methylphenidan
phenidylate
methylphenidate hydrochloride
concerta
methylphenidate HCl

A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

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
30	mg	O

ADMET properties:

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Property	Value	Reference
CL (Clearance)	9.42 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4.80 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.29 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	22 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.20 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.85 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 5, 1955	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
Suicidal ideation	437.33	11.34	350	42076	62071	63384525
Anxiety	279.59	11.34	512	41914	217029	63229567
Product quality issue	250.79	11.34	201	42225	35664	63410932
Product substitution issue	241.38	11.34	144	42282	15852	63430744
Depression	225.73	11.34	441	41985	196051	63250545
Agitation	213.07	11.34	230	42196	59527	63387069
Disturbance in attention	191.59	11.34	177	42249	38012	63408584
Aggression	179.99	11.34	139	42287	23359	63423237
Drug abuse	169.29	11.34	225	42201	72293	63374303
Tachycardia	168.08	11.34	291	42135	117865	63328731

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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	905.34	13.08	433	42142	16602	34897754
Aggression	708.42	13.08	492	42083	38472	34875884
No adverse event	636.22	13.08	378	42197	22549	34891807
Tic	541.28	13.08	168	42407	1890	34912466
Agitation	465.17	13.08	453	42122	56946	34857410
Abnormal behaviour	436.44	13.08	308	42267	24661	34889695
Suicidal ideation	420.93	13.08	367	42208	40021	34874335
Product substitution issue	387.39	13.08	206	42369	9889	34904467
Irritability	357.77	13.08	272	42303	24418	34889938
Psychomotor hyperactivity	332	13.08	183	42392	9439	34904917

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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
Aggression	740.69	11.43	475	62291	50483	79631139
Agitation	632.63	11.43	566	62200	99149	79582473
Suicidal ideation	601.99	11.43	491	62275	75849	79605773
Product substitution issue	550.42	11.43	284	62482	19972	79661650
Tic	509.42	11.43	158	62608	2828	79678794
Abnormal behaviour	478.96	11.43	319	62447	36102	79645520
Irritability	430.07	11.43	313	62453	40831	79640791
Product quality issue	424.06	11.43	288	62478	33652	79647970
Anxiety	323.02	11.43	646	62120	247866	79433756
Attention deficit hyperactivity disorder	315.73	11.43	113	62653	3196	79678426

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N06BA04	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:35471	psychotropic drugs
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:51039	dopamine reuptake inhibitor
FDA EPC	N0000175739	Central Nervous System Stimulant
FDA PE	N0000175729	Central Nervous System Stimulation
MeSH PA	D002491	Central Nervous System Agents

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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
Narcolepsy	indication	60380001	DOID:8986
Attention deficit hyperactivity disorder	indication	406506008
Depressive disorder	off-label use	35489007
Cognitive Impairment following Traumatic Brain Injury	off-label use
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
Mood swings	contraindication	18963009

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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
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10292937	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10617651	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	10881618	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	11241391	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	8916588	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9028868	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9034902	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
100MG	JORNAY PM	IRONSHORE PHARMS	N209311	Aug. 8, 2018	RX	CAPSULE, EXTENDED RELEASE	ORAL	9603809	March 23, 2032	METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10MG/9HR (1.1MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
15MG/9HR (1.6MG/HR)	DAYTRANA	NOVEN PHARMS INC	N021514	April 6, 2006	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9668981	Oct. 7, 2025	METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF

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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
25MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
35MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
45MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
55MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
70MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES
85MG	ADHANSIA XR	PURDUE PHARMA LP	N212038	Feb. 27, 2019	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	June 28, 2024	LABELING REVISIONS RELATED TO CLINICAL STUDIES

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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 dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	Ki	6.96	CHEMBL	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	INHIBITOR	Ki	6.18	CHEMBL	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	5.25	PDSP
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	6.07	PDSP
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	5.62	PDSP
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	4.19	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		IC50	7.08	CHEMBL

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External reference:

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ID	Source
001540	NDDF
004619	NDDF
1038	MMSL
18548003	SNOMEDCT_US
203188	RXNORM
20748-11-2	SECONDARY_CAS_RN
207ZZ9QZ49	UNII
23655-65-4	SECONDARY_CAS_RN
253246	MMSL
32827	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5292	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5292	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5292	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5293	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5293	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5293	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections
Methylphenidate Hydrochloride(CD)	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5295	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	ANDA	34 sections
Ritalin	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0439	TABLET	5 mg	ORAL	NDA	30 sections

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