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Amphetamine
Adderall, Adzenys, 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Adzenys, Evekeo (generic drugs available since 2002-02-11)
Combinations
Adderall, Dyanavel, Mydayis (generic drugs available since 2002-02-11, 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
Tradename
Company
Number
Date
Products
ADZENYS XR-ODTNeos TherapeuticsN-204326 RX2016-01-27
6 products, RLD, RS
Show 1 discontinued
Amphetamine
+
Amphetamine aspartate
+
Dextroamphetamine sulfate
Tradename
Company
Number
Date
Products
DYANAVEL XRTris PharmaN-208147 RX2015-10-19
1 products, RLD, RS
DYANAVEL XR 5Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 10Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 15Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 20Tris PharmaN-210526 RX2021-11-04
1 products, RLD, RS
Amphetamine aspartate
+
Amphetamine sulfate
+
Dextroamphetamine saccharate
+
Dextroamphetamine sulfate
Tradename
Company
Number
Date
Products
ADDERALL XR 25TakedaN-021303 RX2002-05-22
1 products, RLD
ADDERALL XR 5TakedaN-021303 RX2002-05-22
1 products, RLD
ADDERALL XR 15TakedaN-021303 RX2002-05-22
1 products, RLD
ADDERALL XR 10TakedaN-021303 RX2001-10-11
1 products, RLD
ADDERALL XR 20TakedaN-021303 RX2001-10-11
1 products, RLD
ADDERALL XR 30TakedaN-021303 RX2001-10-11
1 products, RLD, RS
MYDAYISTakedaN-022063 RX2017-06-20
4 products, RLD, RS
Show 7 discontinued
Amphetamine resin complex
+
Dextroamphetamine resin complex
Tradename
Company
Number
Date
Products
BIPHETAMINE 20UCBN-010093 DISCN1982-01-01
1 products
BIPHETAMINE 12.5UCBN-010093 DISCN1982-01-01
1 products
BIPHETAMINE 7.5UCBN-010093 DISCN1982-01-01
1 products
Hide discontinued
Amphetamine sulfate
Tradename
Company
Number
Date
Products
EVEKEO ODTAzurityN-209905 RX2019-01-30
4 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
adderallNew Drug Application2022-10-24
adzenys xr-odtNew Drug Application2021-06-02
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateANDA2023-06-14
dyanavel xrNew Drug Application2022-05-31
evekeo odtNew Drug Application2022-10-21
mydayisNew Drug Application2021-01-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
attention deficit disorder with hyperactivityEFO_0003888D001289F90
narcolepsyEFO_0000614D009290G47.4
Agency Specific
FDA
EMA
Expiration
Code
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA
2023-03-13PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Amphetamine / Amphetamine Aspartate/Dextroamphetamine Sulfate, Dyanavel Xr 10, Tris Pharma Inc
115900812038-09-24DPU-3538
83378902027-03-15DP
96757042027-03-15DP
Amphetamine Sulfate, Evekeo Odt, Azurity
104415542037-03-10DP
111607722037-03-10DP
101305802024-04-19DP
Amphetamine / Amphetamine Aspartate/Dextroamphetamine Sulfate, Dyanavel Xr, Tris Pharma Inc
115902282036-09-07DPU-3538
80626672029-03-29DP
85976842027-03-15DP
87479022027-03-15DP
88832172027-03-15DP
96757032027-03-15DP
100860872027-03-15DP
Amphetamine, Adzenys Er, Neos Theraps Inc
87094912032-06-28DP
90177312032-06-28DP
92657372032-06-28DP
Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa
88461002029-08-24DP
91738572026-05-12U-2025
69137682023-05-24DPU-2025
Amphetamine, Adzenys Xr-Odt, Neos Theraps
88409242026-04-09DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA01: Amfetamine
HCPCS
Code
Description
S0160
Dextroamphetamine sulfate, 5 mg
Clinical
Clinical Trials
86 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 hyperactivityD001289EFO_0003888F901998530
Substance-related disordersD019966EFO_0003890F13—1—113
Major depressive disorderD003865EFO_0003761F221——113
Conduct disorderD019955EFO_0004216F91———2—2
Cognitive dysfunctionD060825G31.84—111—2
MotivationD009042———1—1
DeceptionD008192———1—1
Feeding and eating disordersD001068F50———1—1
Attention deficit and disruptive behavior disordersD019958HP_0010865F91.3———1—1
Covid-19D000086382U07.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F148102—117
Multiple sclerosisD009103EFO_0003885G35—22——2
ParentingD016487——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NarcolepsyD009290EFO_0000614G47.421———3
AnhedoniaD059445R45.8411———2
Bipolar disorderD001714EFO_0000289F30.911———2
Short-term memoryD008570EFO_0004335—1———1
AffectD000339—1———1
Autism spectrum disorderD000067877F84.0—1———1
CognitionD003071EFO_0003925—1———1
Idiopathic hypersomniaD020177G47.11—1———1
NeoplasmsD009369C80—1———1
DepressionD003863F33.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6———17
HemodynamicsD0064391————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tobacco use disorderD014029F17————22
StrokeD020521EFO_0000712I63.9————11
AlcoholismD000437EFO_0003829F10.1————11
Opioid-related disordersD009293EFO_0005611F11————11
Obsessive-compulsive disorderD009771EFO_0004242F42————11
Marijuana abuseD002189EFO_0007191F12————11
Respiratory distress syndromeD012128EFO_1000637J80————11
Acute lung injuryD055371EFO_0004610————11
BurnsD002056T30.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMPHETAMINE
INNamfetamine
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 classCNS stimulant, anorectic
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(N)Cc1ccccc1
Identifiers
PDB—
CAS-ID300-62-9
RxCUI—
ChEMBL IDCHEMBL405
ChEBI ID2679
PubChem CID3007
DrugBankDB00182
UNII IDCK833KGX7E (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A3
SLC6A3
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
6531
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
Q14996
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
763
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
P35218
Mouse ortholog
Car5a (12352)
carbonic anhydrase 5A, mitochondrial (P23589)
Variants
Clinical Variant
No data
Financial
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 49,638 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Adzenys xr-odt, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Dyanavel xr, Evekeo odt, Mydayis
Adverse Events
Top Adverse Reactions
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88,713 adverse events reported
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