Amphetamine
Adderall, Adzenys, Amphetamine, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Biphetamine, Delcobese, Dyanavel, Evekeo, Mydayis (amphetamine) is a small molecule pharmaceutical. Amphetamine 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 carbonic anhydrase 5A, mitochondrial, trace amine-associated receptor 1, and carbonic anhydrase 7.
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Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
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Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Adzenys, Amphetamine, Evekeo (discontinued: Adzenys, Amphetamine, Evekeo)
CombinationsAdderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Dyanavel, Mydayis (discontinued: Adderall, Biphetamine, Delcobese, Dextroamp saccharate, amp aspartate, dextroamp amp, Dextroamp saccharate,amp aspartate,dextroamp amp)
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
+
Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| 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 |
| 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 |
| MYDAYIS | Takeda | N-022063 RX | 2017-06-20 | 4 products, RLD, RS |
Show 7 discontinued
Amphetamine
+
Amphetamine aspartate
+
Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DYANAVEL XR | Tris Pharma | N-208147 RX | 2015-10-19 | 1 products, RLD, RS |
| DYANAVEL XR 5 | Tris Pharma | N-210526 RX | 2021-11-04 | 1 products, RLD |
| DYANAVEL XR 10 | Tris Pharma | N-210526 RX | 2021-11-04 | 1 products, RLD |
| DYANAVEL XR 15 | Tris Pharma | N-210526 RX | 2021-11-04 | 1 products, RLD |
| DYANAVEL XR 20 | Tris Pharma | N-210526 RX | 2021-11-04 | 1 products, RLD, RS |
Amphetamine sulfate
Amphetamine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ADZENYS XR-ODT | Neos Therapeutics | N-204326 RX | 2016-01-27 | 6 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adderall | New Drug Application | 2025-03-13 |
| adderall xr | New Drug Application | 2010-03-29 |
| adzenys xr-odt | New Drug Application | 2024-11-07 |
| amphetamine sulfate | ANDA | 2025-02-10 |
| 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 | 2025-04-01 |
| 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 | 2024-12-27 |
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release | ANDA | 2024-01-12 |
Show 11 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amphetamine / Amphetamine Aspartate/Dextroamphetamine Sulfate, Dyanavel Xr 10, Tris Pharma Inc | |||
| 11590081 | 2038-09-24 | DP | U-3538 |
| 8337890 | 2027-03-15 | DP | |
| 9675704 | 2027-03-15 | DP | |
| Amphetamine Sulfate, Evekeo Odt, Azurity | |||
| 10441554 | 2037-03-10 | DP | |
| 11160772 | 2037-03-10 | DP | |
| 11896562 | 2037-03-10 | U-3299 | |
| 10130580 | 2024-04-19 | DP | |
| Amphetamine / Amphetamine Aspartate/Dextroamphetamine Sulfate, Dyanavel Xr, Tris Pharma Inc | |||
| 11590228 | 2036-09-07 | DP | U-3538 |
| 8062667 | 2029-03-29 | DP | |
| 8597684 | 2027-03-15 | DP | |
| 8747902 | 2027-03-15 | DP | |
| 8883217 | 2027-03-15 | DP | |
| 9675703 | 2027-03-15 | DP | |
| 10086087 | 2027-03-15 | DP | |
| Amphetamine, Adzenys Er, Neos Theraps Inc | |||
| 8709491 | 2032-06-28 | DP | |
| 9017731 | 2032-06-28 | DP | |
| 9265737 | 2032-06-28 | DP | |
| Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa | |||
| 8846100 | 2029-08-24 | DP | |
| 9173857 | 2026-05-12 | U-2025 | |
| Amphetamine, Adzenys Xr-Odt, Neos Theraps | |||
| 8840924 | 2026-04-09 | DP | |
HCPCS
Code | Description |
|---|---|
| S0160 | Dextroamphetamine sulfate, 5 mg |
Clinical
Clinical Trials
209 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 | 18 | 11 | 16 | 15 | 62 |
| Hyperkinesis | D006948 | — | — | 5 | 11 | 9 | 10 | 11 | 42 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 3 | 12 | 5 | 1 | 17 | 35 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 2 | 8 | 2 | 3 | 12 | 25 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | — | 1 | 4 | 7 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 3 | — | 1 | 2 | 7 |
| Depression | D003863 | — | F33.9 | — | 2 | — | 2 | 2 | 6 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | 2 | 2 | 6 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 2 | 2 | 4 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | — | 1 | 1 | 4 |
Show 20 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 | 1 | — | 5 | 24 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | 3 | 1 | — | 7 | 10 |
| Heroin dependence | D006556 | EFO_0004240 | — | — | — | 3 | — | 2 | 5 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 1 | 1 | — | 1 | 2 |
| Drug therapy | D004358 | — | — | — | 1 | 1 | — | — | 1 |
| Parenting | D016487 | — | — | — | — | 1 | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 1 | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | — | 1 | — | — | 1 |
| Asthenia | D001247 | EFO_0007625 | R53.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | 1 | — | — | 4 | 15 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | 5 | 7 |
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | 2 | 1 | — | — | 1 | 4 |
| Anhedonia | D059445 | — | R45.84 | 1 | 1 | — | — | — | 2 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | — | 1 | — | — | 1 | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | 1 | 2 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | — | 1 | 2 |
| Hiv seropositivity | D006679 | — | — | — | 1 | — | — | — | 1 |
| Pharmacogenomic testing | D000071185 | — | — | — | 1 | — | — | — | 1 |
| Gambling | D005715 | EFO_1001926 | F63.0 | — | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | 1 | — | — | — | 3 | 4 |
| Drug misuse | D000076064 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | — | — | 3 | 3 |
| Hiv | D006678 | — | O98.7 | — | — | — | — | 2 | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 2 | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 2 | 2 |
| Craving | D066249 | — | — | — | — | — | — | 2 | 2 |
| Personality disorders | D010554 | — | F60.6 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
Show 46 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amphetamine |
| INN | amfetamine |
| Description | 1-phenylpropan-2-amine is a primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group. |
| Classification | Small molecule |
| Drug class | CNS stimulant, anorectic |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(N)Cc1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 300-62-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL405 |
| ChEBI ID | 2679 |
| PubChem CID | 3007 |
| DrugBank | DB00182 |
| UNII ID | CK833KGX7E (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
CA5A
CA5A
TAAR1
TAAR1
CA7
CA7
Organism
Homo sapiens
Gene name
CA5A
Gene synonyms
CA5
NCBI Gene ID
Protein name
carbonic anhydrase 5A, mitochondrial
Protein synonyms
CA-VA, Carbonate dehydratase VA, carbonic anhydrase V, mitochondrial, Carbonic anhydrase VA, carbonic anhydrase VA, mitochondrial, carbonic dehydratase
Uniprot ID
Mouse ortholog
Car5a (12352)
carbonic anhydrase 5A, mitochondrial (P23589)
Variants
No data
Financial
Revenue by drug
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Mydayis – Shire
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Adderall – Shire
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Adderall – Takeda
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Adzenys – Neos Therapeutics
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Estimated US medical usage
Amphetamine
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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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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 55,186 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Adderall xr, Adzenys xr-odt, Amphetamine sulfate, 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, 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, Dyanavel xr, Evekeo, Mixed salts of a single entity amphetamine product, Mixed salts of a single-entity amphetamine product, Mydayis
Adverse Events
Top Adverse Reactions
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50,169 adverse events reported
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