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Drug ReportsAmphetamine aspartate
Amphetamine aspartate
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Mydayis (amphetamine aspartate) is a small molecule pharmaceutical. Amphetamine aspartate was first approved as Adderall 10 on 1996-02-13. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Combinations
Adderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Dyanavel, Mydayis (discontinued: Adderall, 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 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
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
MYDAYISTakedaN-022063 RX2017-06-20
4 products, RLD, RS
Show 7 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
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa
88461002029-08-24DP
91738572026-05-12U-2025
ATC Codes
No data
HCPCS
No data
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 hyperactivityD001289EFO_0003888F9071711161561
HyperkinesisD006948HP_0000752—5119101142
Amphetamine-related disordersD019969EFO_0004701F15312511735
Substance-related disordersD019966EFO_0003890F1327231224
SchizophreniaD012559EFO_0000692F20—2—147
StrokeD020521EFO_0000712I63.913—127
DepressionD003863—F33.9—2—226
Depressive disorderD003866EFO_1002014F32.A—2—226
Major depressive disorderD003865EFO_0003761F22———224
Bipolar disorderD001714EFO_0000289F30.911—114
Show 20 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970—F1410121—525
Addictive behaviorD016739EFO_0004347——31—710
Heroin dependenceD006556EFO_0004240———3—25
Marijuana abuseD002189EFO_0007191F12—11—12
Drug therapyD004358———11——1
ParentingD016487————1——1
Multiple sclerosisD009103EFO_0003885G35—11——1
GliomaD005910EFO_0000520———1——1
AstheniaD001247EFO_0007625R53.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———101——415
Opioid-related disordersD009293EFO_0005611F11—2——57
NarcolepsyD009290HP_0030050G47.421——14
Post-traumatic stress disordersD013313EFO_0001358F43.1—2——13
Traumatic stress disordersD040921———2——13
AnhedoniaD059445—R45.8411———2
Disorders of excessive somnolenceD006970—G47.1—1——12
Hiv seropositivityD006679———1———1
Pharmacogenomic testingD000071185———1———1
GamblingD005715EFO_1001926F63.0—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 disorderD014029—F171———34
Drug misuseD000076064——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——————33
HivD006678——————22
Mental disordersD001523EFO_0000677F91.9————22
AlcoholismD000437EFO_0003829F10.1————22
CravingD066249——————22
Personality disordersD010554HP_0012075F60.6————22
HemorrhageD006470MP_0001914R58————11
Heart failureD006333HP_0001635I50————11
HypertensionD006973EFO_0000537I10————11
Covid-19D000086382——————11
Show 46 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmphetamine aspartate
INN—
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(N)Cc1ccccc1.NC(CC(=O)O)C(=O)O
Identifiers
PDB—
CAS-ID156-34-3
RxCUI—
ChEMBL IDCHEMBL1200377
ChEBI ID—
PubChem CID3007
DrugBankDB00182
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Adderall – Shire
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Adderall – Takeda
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Mydayis – Shire
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 54,201 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Adderall xr, 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, 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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48,646 adverse events reported
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