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Drug ReportsDexmethylphenidate
Dexmethylphenidate
Azstarys, Dexmethylphenidate, Focalin (dexmethylphenidate) is a small molecule pharmaceutical. Dexmethylphenidate was first approved as Focalin on 2001-11-13. It is used to treat attention deficit disorder with hyperactivity in the USA. The pharmaceutical is active against sodium-dependent dopamine transporter. In addition, it is known to target sodium-dependent noradrenaline transporter.
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FDA Novel Drug Approvals 2021
Novartis Pharmaceuticals
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Dexmethylphenidate, Focalin (discontinued: Dexmethylphenidate)
Combinations
Azstarys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexmethylphenidate hydrochloride
+
Serdexmethylphenidate chloride
Tradename
Company
Number
Date
Products
AZSTARYSCommave TherapeuticsN-212994 RX2021-05-07
3 products, RLD, RS
Dexmethylphenidate hydrochloride
Tradename
Company
Number
Date
Products
FOCALINSandozN-021278 RX2001-11-13
3 products, RLD, RS
FOCALIN XRSandozN-021802 RX2005-05-26
8 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
10% methyl salicylate pain relief patchC2002632024-06-27
1st medxpatchC2002632024-10-31
365 whole foods market anticavity/antigingivitis mouthwashOTC monograph not final2022-05-12
5kind dmsoC2002632025-08-04
701 dieda zhengtong yaogao medicatedOTC monograph not final2019-11-13
701 dieda zhengtong yaogao medicated plasterOTC monograph not final2014-06-26
abejas y viboras roll onC2002632025-07-22
absolut skin spf 50 moisturizing sunscreenC2002632025-06-19
advanced antiseptic citrusC2002632025-02-20
advanced citrus antisepticC2002632025-01-10
Show 706 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
DEXMETHYLPHENIDATE HYDROCHLORIDE / SERDEXMETHYLPHENIDATE CHLORIDE, AZSTARYS, COMMAVE THERAP
2026-05-07NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Dexmethylphenidate Hydrochloride / Serdexmethylphenidate Chloride, Azstarys, Commave Therap
105841122037-12-09DS, DP
105841132037-12-09DP
107597782037-12-09DP
108583412037-12-09U-3094
109542132037-12-09U-3094
90799282032-07-27DP
ATC Codes
N: Nervous system drugs
N06: Psychoanaleptics
N06B: Psychostimulants, agents used for adhd and nootropics
N06BA: Centrally acting sympathomimetics
N06BA11: Dexmethylphenidate
N06BA15: Dexmethylphenidate and serdexmethylphenidate
HCPCS
No data
Clinical
Clinical Trials
1780 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients62531483
AnesthesiaD0007587410283178
Major depressive disorderD003865EFO_0003761F222416851061
NeoplasmsD009369C80311124854
Postoperative painD010149G89.18242152042
Emergence deliriumD000071257112162342
Prostatic neoplasmsD011471C6192072337
DeliriumD003693R41.0112132037
PainD010146EFO_0003843R52812331136
Breast neoplasmsD001943EFO_0003869C5091441032
Show 289 more
Indications Phases 3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bipolar disorderD001714EFO_0000289F30.9336
AgingD000375GO_0007568R41.81145
Hepatic insufficiencyD04855033
Pick disease of the brainD020774EFO_0003096G31.01123
Hearing lossD034381EFO_0004238H91.9213
OverweightD050177E66.3123
Addictive behaviorD016739EFO_0004347213
PharmacokineticsD01059933
Heart disease risk factorsD00008274233
VasoconstrictionD01466133
Show 62 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcopeniaD055948EFO_1000653M62.8466
Deglutition disordersD003680R13.133
Brain ischemiaD002545EFO_0003883I67.8233
Trigger finger disorderD052582M65.333
Knee osteoarthritisD020370EFO_0004616M1733
Surgical blood lossD01606333
HypothermiaD007035T6833
Dental plaqueD00377333
Cerebral palsyD002547G8022
Operative surgical proceduresD01351422
Show 217 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDexmethylphenidate
INNdexmethylphenidate
Description
Dexmethylphenidate is a methyl phenyl(piperidin-2-yl)acetate in which both stereocentres have R configuration. It is the active enantiomer in the racemic drug methylphenidate. It has a role as an adrenergic agent. It is an enantiomer of a methyl (S)-phenyl[(S)-piperidin-2-yl]acetate.
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1
Identifiers
PDB
CAS-ID40431-64-9
RxCUI
ChEMBL IDCHEMBL827
ChEBI ID51860
PubChem CID154101
DrugBankDB06701
UNII IDM32RH9MFGP (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A3
SLC6A3
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
Protein name
sodium-dependent dopamine transporter
Protein synonyms
DA transporter, dopamine transporter 1, solute carrier family 6 (neurotransmitter transporter), member 3, solute carrier family 6 (neurotransmitter transporter, dopamine), member 3, Solute carrier family 6 member 3
Uniprot ID
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Alternate
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A2
Gene synonyms
NAT1, NET1, SLC6A5
NCBI Gene ID
Protein name
sodium-dependent noradrenaline transporter
Protein synonyms
NET, neurotransmitter transporter, Norepinephrine transporter, solute carrier family 6 (neurotransmitter transporter), member 2, solute carrier family 6 (neurotransmitter transporter, noradrenalin), member 2, Solute carrier family 6 member 2, solute carrier family 6 member 5
Uniprot ID
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Variants
No data
Financial
Revenue by drug
$
£
Concerta Johnson & Johnson
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Bloxiverz Avadel Pharmaceuticals
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Daytrana Shire
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Medrol Pfizer
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Methylphenidate RVL Pharmaceuticals
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Tabular view
Estimated US medical usage
Dexmethylphenidate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 730,041 documents
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Safety
Black-box Warning
Black-box warning for: Aptensio xr, Azstarys, Concerta, Cotempla xr-odt, Covaryx, Covaryx covaryx, Daytrana, Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride extended-release, Diclovix m, Dyural 40 kit, Dyural 80 kit, Dyural 80-lm, Dyural lm kit, Eemt, Eemt eemt, Esterified estrogens and methyltestosterone, Esterified estrogens and methyltestosterone full strength esterified estrogens and methyltestosterone half strength, Estratest f.s., Estratest f.s. estratest h.s., Estratest fs estratest hs, Fenovar, Focalin, Focalin xr, Focalinxr, Healthy mamabe well rounded, Hycodan, Hydrocodone bitartrate and homatropine methylbromide, Hydromet, Jornay pm, Metadate cd, Metadate er, Methylene blue, Methylin, Methylphenidate, Methylphenidate hydrochloride, Methylphenidate hydrochloride (la), Methylphenidate hydrochloride extended release, Methylphenidate transdermal system, Orthaphen, Perseris, Physicians ez use m-pred, Prenate elite, Prenate essential, Provayblue, Quillichew er, Quillivant, Relexxii, Ritalin, Varophen
Adverse Events
Top Adverse Reactions
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237,070 adverse events reported
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