Dextroamphetamine
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Biphetamine, Delcobese, Dexedrine, Dextroamphetamine, 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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
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
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Amphetamine sulfate
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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
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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 | 2023-10-25 |
| adderall xr | New Drug Application | 2010-03-29 |
| dexedrine | New Drug Application | 2023-10-23 |
| dextroamphetamine | ANDA | 2023-10-23 |
| dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate | ANDA | 2023-10-20 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate | ANDA | 2024-02-01 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate dextroamphetamine saccharate, am... | ANDA | 2020-10-02 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate | ANDA | 2024-02-05 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release | ANDA | 2024-02-01 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate | ANDA | 2024-01-12 |
Show 14 more
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
139 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 | 5 | 13 | 8 | 13 | 12 | 47 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 4 | — | 1 | 1 | 6 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | 1 | 1 | 4 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | 1 | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 1 | — | 1 | — | 2 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 2 | — | 2 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 1 | 1 | 1 | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 9 | 12 | 2 | — | 3 | 23 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | 1 | — | — | 3 | 11 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | 2 | 3 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | 2 | 3 |
| Narcolepsy | D009290 | HP_0030050 | G47.4 | 2 | 1 | — | — | — | 3 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | 3 | — | — | — | 3 |
| Anhedonia | D059445 | — | R45.84 | 1 | 1 | — | — | — | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | — | — | — | 2 |
| Short-term memory | D008570 | EFO_0004335 | — | — | 1 | — | — | — | 1 |
| Affect | D000339 | — | — | — | 1 | — | — | — | 1 |
| Gambling | D005715 | EFO_1001926 | F63.0 | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemodynamics | D006439 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | — | — | — | — | 3 | 3 |
| Hiv | D006678 | — | O98.7 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
Show 24 more
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 |
Identifiers
| PDB | — |
| CAS-ID | 51-64-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL612 |
| ChEBI ID | 4469 |
| PubChem CID | 5826 |
| DrugBank | DB01576 |
| UNII ID | TZ47U051FI (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Estimated US medical usage
Dextroamphetamine
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Amphetamine
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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Dextroamphetamine
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 5,677 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Adderall xr, Dexedrine, Dextroamphetamine, Dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate dextroamphetamine saccharate, am..., Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets,cii, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine sulfate, Mixed salts of a single entity amphetamine product, Mixed salts of a single-entity amphetamine product, Mydayis, Xelstrym, Zenzedi
Adverse Events
Top Adverse Reactions
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22,377 adverse events reported
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