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.
Download report
Favorite
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
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
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 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 |
| 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 |
| RITALIN | Sandoz | N-010187 RX | 1982-01-01 | 3 products, RLD, RS |
| RITALIN LA | Sandoz | N-021284 RX | 2002-06-05 | 4 products, RLD |
| METHYLIN | SPECGX | N-021419 RX | 2002-12-19 | 2 products, RLD, RS |
Show 4 discontinued
Methylphenidate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COTEMPLA XR-ODT | Neos Therapeutics | N-205489 RX | 2017-06-19 | 3 products, RLD, RS |
| DAYTRANA | Noven Pharmaceuticals | N-021514 RX | 2006-04-06 | 4 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aptensio xr | New Drug Application | 2024-04-08 |
| concerta | New Drug Application | 2024-10-03 |
| cotempla xr-odt | New Drug Application | 2024-03-27 |
| daytrana | New Drug Application | 2024-04-12 |
| jornay pm | New Drug Application | 2023-10-19 |
| metadate cd | New Drug Application | 2023-10-31 |
| metadate er | ANDA | 2017-05-22 |
| methylin | New Drug Application | 2024-06-26 |
| methylin methylin | ANDA | 2010-11-17 |
| methylin methylin methylphenidate hydrochloride methylphenidate hydrochloride | ANDA | 2011-07-12 |
Show 16 more
Indications
FDA
EMA
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
507 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 14 | 30 | 57 | 104 | 80 | 273 |
| Hyperkinesis | D006948 | HP_0000752 | — | 5 | 20 | 41 | 71 | 62 | 192 |
| Healthy volunteers/patients | — | — | — | 9 | 1 | 2 | 5 | 8 | 25 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 3 | 2 | 2 | 3 | 7 | 17 |
| Cocaine-related disorders | D019970 | — | F14 | 7 | 6 | 1 | 1 | 2 | 16 |
| Brain injuries | D001930 | — | S06.9 | 2 | 5 | — | 3 | 1 | 10 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | 2 | 6 | 1 | 10 |
| Depression | D003863 | — | F33.9 | 1 | 2 | 4 | 2 | 2 | 10 |
| Apathy | D057565 | HP_0000741 | — | 1 | 2 | 1 | 3 | 2 | 9 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 4 | 1 | 4 | 1 | 9 |
Show 63 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 | 2 | 11 | 12 | — | 2 | 23 |
| Neoplasms | D009369 | — | C80 | 1 | 4 | 7 | — | 3 | 13 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 3 | 2 | — | — | 5 |
| Sclerosis | D012598 | — | — | 1 | 3 | 2 | — | — | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | 4 | 1 | — | — | 4 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | — | 2 | 1 | — | 2 | 4 |
| Smoking | D012907 | EFO_0004318 | — | — | 1 | 1 | — | 2 | 4 |
| Dyssomnias | D020920 | — | — | — | 2 | 1 | — | 1 | 3 |
| Parasomnias | D020447 | — | G47.5 | — | 2 | 1 | — | 1 | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 2 | 2 | 1 | — | — | 3 |
Show 24 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep wake disorders | D012893 | — | G47 | — | 2 | — | — | 1 | 3 |
| Tobacco use disorder | D014029 | — | F17 | 1 | 1 | — | — | 1 | 3 |
| Consciousness disorders | D003244 | — | — | 2 | 1 | — | — | — | 2 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | 1 | — | — | 1 | 2 |
| Delayed emergence from anesthesia | D055191 | — | — | 2 | 1 | — | — | — | 2 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 1 | — | — | 1 | 2 |
| Feeding and eating disorders | D001068 | — | F50 | — | 1 | — | — | 1 | 2 |
| Sleepiness | D000077260 | — | R40.0 | — | 1 | — | — | 1 | 2 |
| Addictive behavior | D016739 | EFO_0004347 | — | 1 | 1 | — | — | 1 | 2 |
| Bulimia | D002032 | — | F50.2 | — | 1 | — | — | — | 1 |
Show 16 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Impulsive behavior | D007175 | — | — | 2 | — | — | — | — | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | — | — | — | — | 1 |
| Psilocybe | D055391 | — | — | 1 | — | — | — | — | 1 |
| Coma | D003128 | HP_0001259 | R40.2 | 1 | — | — | — | — | 1 |
| Motivation | D009042 | — | — | 1 | — | — | — | — | 1 |
| Social cognition | D000083282 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Personality disorders | D010554 | HP_0012075 | F60.6 | — | — | — | — | 3 | 3 |
| Hiv | D006678 | — | — | — | — | — | — | 1 | 1 |
| Memory consolidation | D000069077 | — | — | — | — | — | — | 1 | 1 |
| Heat stress disorders | D018882 | — | T67.2 | — | — | — | — | 1 | 1 |
| Palliative care | D010166 | — | — | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | — | — | 1 | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
Show 45 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | Central nervous system stimulant & norepinephrine–dopamine reuptake inhibitor |
| 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
No data
Financial
Revenue by drug
$
€
£
â‚£
Daytrana – Shire
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Concerta – Johnson & Johnson
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Methylphenidate – RVL Pharmaceuticals
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Cotempla – Neos Therapeutics
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Methylphenidate
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 23,329 documents
View more details
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
Mock data
Subscribe for the real data
Subscribe for the real data
48,897 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use