Dextroamphetamine
Adderall, Biphetamine, Delcobese, Dexedrine, Mydayis, Xelstrym (dextroamphetamine) is a small molecule pharmaceutical. Dextroamphetamine was first approved as Delcobese on 1982-01-01. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA. The pharmaceutical is active against sodium-dependent dopamine transporter and sodium-dependent noradrenaline transporter. In addition, it is known to target trace amine-associated receptor 1.
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Commercial
Trade Name
FDA
EMA
Dexedrine, Xelstrym (generic drugs available since 2001-01-31, discontinued: Dexampex, Dextrostat, Ferndex)
CombinationsAdderall, Mydayis (generic drugs available since 2001-01-31, discontinued: Biphetamine, Delcobese)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphetamine aspartate
+
Amphetamine sulfate
+
Dextroamphetamine saccharate
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Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ADDERALL XR 25 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
ADDERALL XR 5 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
ADDERALL XR 15 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
ADDERALL XR 10 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
ADDERALL XR 20 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
ADDERALL XR 30 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD, RS |
MYDAYIS | Takeda | N-022063 RX | 2017-06-20 | 4 products, RLD, RS |
Show 7 discontinued
Amphetamine resin complex
+
Dextroamphetamine resin complex
Dextroamphetamine
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
XELSTRYM | Noven Pharmaceuticals | N-215401 RX | 2022-03-22 | 4 products, RLD, RS |
Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DEXEDRINE | Impax Laboratories | N-017078 RX | 1982-01-01 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
adderall | New Drug Application | 2022-10-24 |
dexedrine | New Drug Application | 2019-06-17 |
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate | ANDA | 2023-06-14 |
mydayis | New Drug Application | 2021-01-06 |
xelstrym | New Drug Application | 2022-12-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
narcolepsy | EFO_0000614 | D009290 | G47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
DEXTROAMPHETAMINE, XELSTRYM, NOVEN PHARMS INC | |||
2025-03-22 | NP | ||
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA | |||
2023-03-13 | PED |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Dextroamphetamine, Xelstrym, Noven Pharms Inc | |||
11559501 | 2042-01-06 | DP | |
9456993 | 2033-10-24 | DP | U-3340 |
9474722 | 2033-10-24 | DP | |
8591941 | 2025-10-07 | DP | |
8632802 | 2025-10-07 | DP | |
9034370 | 2025-10-07 | DP | |
Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa | |||
8846100 | 2029-08-24 | DP | |
9173857 | 2026-05-12 | U-2025 | |
6913768 | 2023-05-24 | DP | U-2025 |
HCPCS
Code | Description |
---|---|
S0160 | Dextroamphetamine sulfate, 5 mg |
Clinical
Clinical Trials
82 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 | — | 7 | 5 | 5 | 4 | 19 |
Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | 1 | 1 | 4 |
Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 2 | — | 2 |
Cognitive dysfunction | D060825 | G31.84 | — | 1 | 1 | 1 | — | 2 | |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
Motivation | D009042 | — | — | — | 1 | — | 1 | ||
Deception | D008192 | — | — | — | 1 | — | 1 | ||
Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | 1 | — | 1 |
Dementia | D003704 | F03 | — | — | — | 1 | — | 1 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cocaine-related disorders | D019970 | F14 | 8 | 11 | 2 | — | 1 | 20 | |
Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 2 | — | — | 2 |
Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | 2 | 3 |
Narcolepsy | D009290 | EFO_0000614 | G47.4 | 2 | 1 | — | — | — | 3 |
Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | 1 | 2 |
Anhedonia | D059445 | R45.84 | 1 | 1 | — | — | — | 2 | |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | — | — | — | 2 |
Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | — | 2 |
Short-term memory | D008570 | EFO_0004335 | — | 1 | — | — | — | 1 | |
Affect | D000339 | — | 1 | — | — | — | 1 | ||
Gambling | D005715 | F63.0 | — | 1 | — | — | — | 1 | |
Idiopathic hypersomnia | D020177 | G47.11 | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 5 | — | — | — | — | 5 | ||
Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | 1 | 2 |
Hemodynamics | D006439 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Psychotic disorders | D011618 | F20.81 | — | — | — | — | 1 | 1 | |
Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 1 | 1 |
Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | — | — | — | 1 | 1 |
Tobacco use disorder | D014029 | F17 | — | — | — | — | 1 | 1 | |
Marijuana abuse | D002189 | EFO_0007191 | F12 | — | — | — | — | 1 | 1 |
Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DEXTROAMPHETAMINE |
INN | dexamfetamine |
Description | (S)-amphetamine is a 1-phenylpropan-2-amine that has S configuration. It has a role as a neurotoxin, an adrenergic uptake inhibitor, a dopaminergic agent, a sympathomimetic agent, a dopamine uptake inhibitor and an adrenergic agent. It is an enantiomer of a (R)-amphetamine. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C[C@H](N)Cc1ccccc1 |
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)
Variants
Clinical Variant
No data
Financial
Mydayis - Shire
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Adderall - Shire
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Adderall - Takeda
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,004 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Dexedrine, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Mydayis, Xelstrym
Adverse Events
Top Adverse Reactions
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108,223 adverse events reported
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