Methylphenidate
Aptensio, Concerta, Cotempla, Daytrana, Jornay, Metadate, Methylin, 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
Commercial
Trade Name
FDA
EMA
Aptensio, Concerta, Cotempla, Daytrana, Jornay, Metadate, Methylin, Quillichew, Quillivant, Relexxii, Ritalin (generic drugs available since 1998-11-27, discontinued: Adhansia, 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
Methylphenidate hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| METADATE CD | Aytu Biopharma | N-021259 RX | 2001-04-03 | 6 products, RLD |
| JORNAY PM | Ironshore Pharmaceuticals | N-209311 RX | 2018-08-08 | 5 products, RLD, RS |
| CONCERTA | Johnson & Johnson | N-021121 RX | 2000-08-01 | 4 products, RLD |
| QUILLIVANT XR | NextWave Pharmaceuticals | N-202100 RX | 2012-09-27 | 1 products, RLD, RS |
| QUILLICHEW ER | NextWave Pharmaceuticals | N-207960 RX | 2015-12-04 | 3 products, RLD, RS |
| RITALIN | Novartis | N-010187 RX | 1982-01-01 | 3 products, RLD, RS |
| RITALIN LA | Novartis | N-021284 RX | 2002-06-05 | 4 products, RLD |
| RELEXXII | RVL Pharmaceuticals | N-216117 RX | 2022-06-23 | 7 products, RLD, RS |
| APTENSIO XR | Rhodes Pharmaceuticals | N-205831 RX | 2015-04-17 | 7 products, RLD, RS |
| METHYLIN | SPECGX | N-021419 RX | 2002-12-19 | 2 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adhansia xr | New Drug Application | 2021-06-02 |
| aptensio xr | New Drug Application | 2021-06-30 |
| concerta | New Drug Application | 2021-07-01 |
| cotempla xr-odt | New Drug Application | 2020-01-22 |
| daytrana | New Drug Application | 2019-12-09 |
| jornay pm | New Drug Application | 2021-06-30 |
| metadate er | ANDA | 2017-05-22 |
| methylin | New Drug Application | 2021-07-23 |
| methylphenidate hydrochloride | ANDA | 2023-06-12 |
| quillichew er | New Drug Application | 2021-06-30 |
Show 3 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
| depressive disorder | EFO_1002014 | D003866 | F32.A |
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE, ADHANSIA XR, PURDUE PHARMA LP | |||
| 2024-06-28 | M-82 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Methylphenidate Hydrochloride, Adhansia Xr, Purdue Pharma Lp | |||
| 10722473 | 2038-11-19 | U-2357 | |
| 9974752 | 2035-10-30 | DP | |
| 10111839 | 2035-10-30 | U-2357 | |
| 10292938 | 2035-10-30 | DP | |
| 10292939 | 2035-10-30 | DP | U-2357 |
| 10449159 | 2035-10-30 | U-2357 | |
| 10500162 | 2035-10-30 | U-2357 | |
| 10507186 | 2035-10-30 | DP | |
| 10512612 | 2035-10-30 | DP | |
| 10512613 | 2035-10-30 | U-2357 | |
| 10568841 | 2035-10-30 | DP | U-2357 |
| 10688060 | 2035-10-30 | DP | |
| Methylphenidate, Cotempla Xr-Odt, Neos Theraps Inc | |||
| 11166947 | 2038-01-25 | U-3299 | |
| 9072680 | 2032-06-28 | DP | |
| 9089496 | 2032-06-28 | DP | |
| 8840924 | 2026-06-05 | DP | |
| Methylphenidate Hydrochloride, Quillichew Er, Nextwave Pharms | |||
| 8999386 | 2033-08-14 | DP | |
| 9295642 | 2033-08-14 | DP | U-1827 |
| 9545399 | 2033-08-14 | DP | U-1827 |
| 9844544 | 2033-08-14 | DP | U-2203 |
| 10857143 | 2033-08-14 | DP | U-2993 |
| 11103494 | 2033-08-14 | DP | |
| 11103495 | 2033-08-14 | DP | U-2993 |
| 11633389 | 2033-08-14 | DP | |
| 8287903 | 2031-02-15 | DP | |
| 8202537 | 2027-03-15 | DP | |
| Methylphenidate Hydrochloride, Jornay Pm, Ironshore Pharms | |||
| 8916588 | 2032-03-23 | U-2357 | |
| 8927010 | 2032-03-23 | DP | |
| 9023389 | 2032-03-23 | DP | |
| 9028868 | 2032-03-23 | U-2357 | |
| 9034902 | 2032-03-23 | U-2357 | |
| 9283214 | 2032-03-23 | DP | |
| 9498447 | 2032-03-23 | DP | |
| 9603809 | 2032-03-23 | U-2357 | |
| 10182995 | 2032-03-23 | DP | |
| 10292937 | 2032-03-23 | U-2357 | |
| 10617651 | 2032-03-23 | U-2357 | |
| 10881618 | 2032-03-23 | U-2357 | |
| 10905652 | 2032-03-23 | DP | |
| 11241391 | 2032-03-23 | U-2357 | |
| 11241392 | 2032-03-23 | DP | |
| Methylphenidate Hydrochloride, Quillivant Xr, Nextwave | |||
| 8465765 | 2031-02-15 | DP | U-1415 |
| 8563033 | 2031-02-15 | DP | U-1415 |
| 8778390 | 2031-02-15 | DP | U-1543 |
| 8956649 | 2031-02-15 | DP | U-1665 |
| 9040083 | 2031-02-15 | DP | |
| 8062667 | 2029-03-29 | DP | |
| Methylphenidate, Daytrana, Noven Pharms Inc | |||
| 8632802 | 2025-10-07 | DP | |
| 9034370 | 2025-10-07 | DP | |
| 9668981 | 2025-10-07 | U-2024 | |
| Methylphenidate Hydrochloride, Methylin, Specgx Llc | |||
| 7691880 | 2024-10-07 | DP | |
HCPCS
No data
Clinical
Clinical Trials
386 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 hyperactivity | D001289 | EFO_0003888 | F90 | 9 | 24 | 45 | 79 | 38 | 185 |
| Healthy volunteers/patients | — | 6 | 1 | 2 | 5 | 7 | 21 | ||
| Cocaine-related disorders | D019970 | F14 | 5 | 4 | 1 | 1 | 1 | 11 | |
| Apathy | D057565 | 1 | 2 | 1 | 3 | 1 | 8 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 2 | — | 3 | 1 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | 4 | 1 | 7 |
| Dementia | D003704 | F03 | — | — | — | 5 | 1 | 6 | |
| Depression | D003863 | F33.9 | — | 2 | 3 | 1 | 1 | 6 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 2 | 1 | 2 | — | 6 |
| Traumatic brain injuries | D000070642 | S06 | — | 3 | — | 2 | — | 5 |
Show 32 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | HP_0012378 | R53.83 | 1 | 6 | 7 | — | 1 | 13 |
| Neoplasms | D009369 | C80 | 1 | 3 | 7 | — | 1 | 10 | |
| Prostatic neoplasms | D011471 | C61 | — | 4 | 1 | — | — | 4 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 2 | — | — | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 2 | 1 | — | — | 2 |
| Smoking | D012907 | EFO_0003768 | F17 | — | 1 | 1 | — | — | 2 |
| Asthenia | D001247 | EFO_0007625 | R53.1 | — | — | 2 | — | — | 2 |
| Delirium | D003693 | R41.0 | — | — | 1 | — | — | 1 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | C26.9 | — | — | 1 | — | — | 1 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | 3 | — | — | — | 4 |
| Sleep wake disorders | D012893 | G47 | — | 2 | — | — | — | 2 | |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | 1 | — | — | — | 2 |
| Binge-eating disorder | D056912 | F50.2 | — | 1 | — | — | — | 1 | |
| Anesthesia | D000758 | 1 | 1 | — | — | — | 1 | ||
| Male breast neoplasms | D018567 | — | 1 | — | — | — | 1 | ||
| Cognition disorders | D003072 | — | 1 | — | — | — | 1 | ||
| Hoarding disorder | D000067836 | F42.3 | — | 1 | — | — | — | 1 | |
| Apraxias | D001072 | HP_0011098 | R48.2 | — | 1 | — | — | — | 1 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Impulsive behavior | D007175 | 2 | — | — | — | — | 2 | ||
| Pure autonomic failure | D054970 | 1 | — | — | — | — | 1 | ||
| Orthostatic hypotension | D007024 | I95.1 | 1 | — | — | — | — | 1 | |
| Delayed emergence from anesthesia | D055191 | 1 | — | — | — | — | 1 | ||
| Tobacco use disorder | D014029 | F17 | 1 | — | — | — | — | 1 | |
| Coma | D003128 | HP_0001259 | R40.2 | 1 | — | — | — | — | 1 |
| Consciousness disorders | D003244 | 1 | — | — | — | — | 1 | ||
| Motivation | D009042 | 1 | — | — | — | — | 1 | ||
| Social cognition | D000083282 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Palliative care | D010166 | — | — | — | — | 1 | 1 | ||
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 1 | 1 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | — | — | — | 1 | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | 1 | ||
| Decision making | D003657 | — | — | — | — | 1 | 1 | ||
| Neurofeedback | D058765 | — | — | — | — | 1 | 1 | ||
| Hyperthermia | D000084462 | — | — | — | — | 1 | 1 | ||
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Separation anxiety | D001010 | EFO_1001916 | — | — | — | — | 1 | 1 | |
| Enuresis | D004775 | R32 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | METHYLPHENIDATE |
| INN | methylphenidate |
| 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 class | CNS stimulant & NDRI |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)C(c1ccccc1)C1CCCCN1 |
Identifiers
| PDB | — |
| CAS-ID | 113-45-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL796 |
| ChEBI ID | 84276 |
| PubChem CID | 4158 |
| DrugBank | DB00422 |
| UNII ID | 207ZZ9QZ49 (ChemIDplus, GSRS) |
Target
Agency Approved
SLC6A3
SLC6A3
SLC6A2
SLC6A2
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
No data
Variants
Clinical Variant
No data
Financial
Methylphenidate - RVL Pharmaceuticals
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Daytrana - Shire
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Cotempla - Neos Therapeutics
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Concerta - Johnson & Johnson
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Tabular view
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Adhansia xr, Aptensio xr, Concerta, Cotempla xr-odt, Daytrana
, Jornay pm , Metadate er, Methylin, Methylphenidate hydrochloride, Quillichew er, Quillivant, Relexxii, Ritalin
Adverse Events
Top Adverse Reactions
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1,456 adverse events reported
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