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Drug ReportsDextroamphetamine
Dextroamphetamine
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Biphetamine, Delcobese, Dexedrine Spansule, 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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Dexedrine spansule, Dextroamphetamine, Xelstrym (discontinued: Dexampex, Dexedrine, Dextroamphetamine, Dextrostat, Ferndex)
Combinations
Adderall, 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 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
Dextroamphetamine sulfate
Tradename
Company
Number
Date
Products
DEXEDRINE SPANSULEImpax LaboratoriesN-017078 RX1982-01-01
3 products, RLD, RS
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
Dextroamphetamine
Tradename
Company
Number
Date
Products
XELSTRYMNoven PharmaceuticalsN-215401 RX2022-03-22
4 products, RLD, RS
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
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Labels
FDA
EMA
Brand Name
Status
Last Update
adderallNew Drug Application2025-03-13
adderall xrNew Drug Application2010-03-29
dexedrineNew Drug Application2023-10-23
dextroamphetamineANDA2025-03-26
dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfateANDA2023-10-20
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfateANDA2025-03-17
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateANDA2024-02-05
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-releaseANDA2024-02-01
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateANDA2024-12-27
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-releaseANDA2024-01-12
Show 13 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
narcolepsyEFO_0000614D009290G47.4
attention deficit disorder with hyperactivityEFO_0003888D001289F90
Agency Specific
FDA
EMA
Expiration
Code
DEXTROAMPHETAMINE, XELSTRYM, NOVEN PHARMS INC
2025-03-22NP
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA
2023-03-13PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Dextroamphetamine, Xelstrym, Noven Pharms Inc
115595012042-01-06DP
94569932033-10-24DPU-3340
94747222033-10-24DP
85919412025-10-07DP
86328022025-10-07DP
90343702025-10-07DP
Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa
88461002029-08-24DP
91738572026-05-12U-2025
69137682023-05-24DPU-2025
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA02: Dexamfetamine
HCPCS
Code
Description
S0160
Dextroamphetamine sulfate, 5 mg
Clinical
Clinical Trials
108 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Attention deficit disorder with hyperactivityD001289EFO_0003888F90—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDextroamphetamine
INNdexamfetamine
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)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@H](N)Cc1ccccc1
Identifiers
PDB—
CAS-ID51-64-9
RxCUI—
ChEMBL IDCHEMBL612
ChEBI ID4469
PubChem CID5826
DrugBankDB01576
UNII IDTZ47U051FI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Adderall – Shire
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Adderall – Takeda
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Mydayis – Shire
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Estimated US medical usage
Dextroamphetamine
+
Amphetamine
Total medical expenditures per year (USD, in millions)
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Dextroamphetamine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,967 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, 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, Procentra, Xelstrym, Zenzedi
Adverse Events
Top Adverse Reactions
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35,867 adverse events reported
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