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Drug ReportsMethylphenidate
Methylphenidate
Aptensio, Concerta, Cotempla, Daytrana, Jornay, Metadate, Methylin, Methylphenidate, Quillichew, Quillivant, Relexxii, Ritalin (methylphenidate) is a small molecule pharmaceutical. Methylphenidate was first approved as Ritalin on 1982-01-01. It is used to treat attention deficit disorder with hyperactivity, depressive disorder, and narcolepsy in the USA. The pharmaceutical is active against sodium-dependent dopamine transporter and sodium-dependent noradrenaline transporter.
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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
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Aptensio, Concerta, Cotempla, Daytrana, Jornay, Metadate, Methylin, Methylphenidate, Quillichew, Quillivant, Relexxii, Ritalin (discontinued: Adhansia, Cotempla, Metadate, Methylin, Methylphenidate, Ritalin, Ritalin-sr)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methylphenidate
Tradename
Company
Number
Date
Products
COTEMPLA XR-ODTNeos TherapeuticsN-205489 RX2017-06-19
3 products, RLD, RS
DAYTRANANoven PharmaceuticalsN-021514 RX2006-04-06
4 products, RLD, RS
Show 1 discontinued
Methylphenidate hydrochloride
Tradename
Company
Number
Date
Products
METADATE CDAytu BiopharmaN-021259 RX2001-04-03
6 products, RLD
JORNAY PMIronshore PharmaceuticalsN-209311 RX2018-08-08
5 products, RLD, RS
CONCERTAJohnson & JohnsonN-021121 RX2000-08-01
4 products, RLD
QUILLIVANT XRNextWave PharmaceuticalsN-202100 RX2012-09-27
1 products, RLD, RS
QUILLICHEW ERNextWave PharmaceuticalsN-207960 RX2015-12-04
3 products, RLD, RS
RELEXXIIRVL PharmaceuticalsN-216117 RX2022-06-23
7 products, RLD, RS
APTENSIO XRRhodes PharmaceuticalsN-205831 RX2015-04-17
7 products, RLD, RS
RITALIN LASandozN-021284 RX2002-06-05
4 products, RLD
RITALINSandozN-010187 RX1982-01-01
3 products, RLD, RS
METHYLINSPECGXN-021419 RX2002-12-19
2 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aptensio xrNew Drug Application2025-09-25
concertaNew Drug Application2025-09-30
cotempla xr-odtNew Drug Application2025-08-21
daytranaNew Drug Application2025-09-01
jornay pmNew Drug Application2023-10-19
metadate cdNew Drug Application2023-10-31
metadate erANDA2017-05-22
methylinNew Drug Application2024-06-26
methylin methylinANDA2010-11-17
methylin methylin methylphenidate hydrochloride methylphenidate hydrochlorideANDA2011-07-12
Show 16 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
narcolepsyEFO_0000614D009290G47.4
attention deficit disorder with hyperactivityEFO_0003888D001289F90
depressive disorderEFO_1002014D003866F32.A
Agency Specific
FDA
EMA
Expiration
Code
METHYLPHENIDATE HYDROCHLORIDE, ADHANSIA XR, PURDUE PHARMA LP
2024-06-28M-82
Patent Expiration
Patent
Expires
Flag
FDA Information
Methylphenidate Hydrochloride, Adhansia Xr, Purdue Pharma Lp
107224732038-11-19U-2357
99747522035-10-30DP
101118392035-10-30U-2357
102929382035-10-30DP
102929392035-10-30DPU-2357
104491592035-10-30U-2357
105001622035-10-30U-2357
105071862035-10-30DP
105126122035-10-30DP
105126132035-10-30U-2357
105688412035-10-30DPU-2357
106880602035-10-30DP
Methylphenidate, Cotempla Xr-Odt, Neos Theraps Inc
111669472038-01-25U-3299
90726802032-06-28DP
90894962032-06-28DP
88409242026-06-05DP
Methylphenidate Hydrochloride, Quillichew Er, Nextwave Pharms
89993862033-08-14DP
92956422033-08-14DPU-1827
95453992033-08-14DPU-1827
98445442033-08-14DPU-2203
108571432033-08-14DPU-2993
111034942033-08-14DP
111034952033-08-14DPU-2993
116333892033-08-14DP
82879032031-02-15DP
82025372027-03-15DP
Methylphenidate Hydrochloride, Jornay Pm, Ironshore Pharms
89165882032-03-23U-2357
89270102032-03-23DP
90233892032-03-23DP
90288682032-03-23U-2357
90349022032-03-23U-2357
92832142032-03-23DP
94984472032-03-23DP
96038092032-03-23U-2357
101829952032-03-23DP
102929372032-03-23U-2357
106176512032-03-23U-2357
108816182032-03-23U-2357
109056522032-03-23DP
112413912032-03-23U-2357
112413922032-03-23DP
Methylphenidate Hydrochloride, Quillivant Xr, Nextwave
84657652031-02-15DPU-1415
85630332031-02-15DPU-1415
87783902031-02-15DPU-1543
89566492031-02-15DPU-1665
90400832031-02-15DP
80626672029-03-29DP
Methylphenidate, Daytrana, Noven Pharms Inc
86328022025-10-07DP
90343702025-10-07DP
96689812025-10-07U-2024
Methylphenidate Hydrochloride, Methylin, Specgx Llc
76918802024-10-07DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA04: Methylphenidate
HCPCS
No data
Clinical
Clinical Trials
527 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Attention deficit disorder with hyperactivityD001289EFO_0003888F90——43—7
HyperkinesisD006948————23—5
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMethylphenidate
INNmethylphenidate
Description
Methyl phenyl(piperidin-2-yl)acetate is a amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group. It is a member of piperidines, a methyl ester and a beta-amino acid ester.
Classification
Small molecule
Drug classCentral nervous system stimulant & norepinephrine–dopamine reuptake inhibitor
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COC(=O)C(c1ccccc1)C1CCCCN1
Identifiers
PDB—
CAS-ID113-45-1
RxCUI—
ChEMBL IDCHEMBL796
ChEBI ID84276
PubChem CID4158
DrugBankDB00422
UNII ID207ZZ9QZ49 (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A3
SLC6A3
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
6531
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
Q14996
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Cotempla – Neos Therapeutics
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Daytrana – Shire
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Concerta – Johnson & Johnson
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Methylphenidate – RVL Pharmaceuticals
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Tabular view
Estimated US medical usage
Methylphenidate
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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 24,203 documents
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Safety
Black-box Warning
Black-box warning for: Aptensio xr, Concerta, Cotempla xr-odt, Daytrana, Jornay pm, Metadate cd, Metadate er, Methylin, Methylphenidate, Methylphenidate hydrochloride, Methylphenidate hydrochloride (la), Methylphenidate hydrochloride extended release, Methylphenidate transdermal system, Quillichew er, Quillivant, Relexxii, Ritalin
Adverse Events
Top Adverse Reactions
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49,187 adverse events reported
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