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Dutetrabenazine
Austedo (dutetrabenazine) is a small molecule pharmaceutical. Dutetrabenazine was first approved as Austedo on 2017-04-03.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Austedo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Deutetrabenazine
Tradename
Company
Number
Date
Products
AUSTEDO XRTevaN-216354 RX2023-02-17
3 products, RLD, RS
AUSTEDOTevaN-208082 RX2017-04-03
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
austedoNew Drug Application2020-12-14
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
DEUTETRABENAZINE, AUSTEDO, TEVA BRANDED PHARM
2024-12-24PED
2024-10-03PED
2024-06-24M-54
2024-04-03ODE-134
Patent Expiration
Patent
Expires
Flag
FDA Information
Deutetrabenazine, Austedo Xr, Teva
113114882041-06-10DPU-1995, U-3055
Deutetrabenazine, Austedo, Teva Branded Pharm
111793862038-03-15DPU-1995, U-3055
109599962036-03-07U-3055
113577722036-03-07U-1995, U-3055
114462912036-03-07U-1995
115649172036-03-07U-1995
116482442036-03-07U-1995
92339592033-09-18DP
92967392033-09-18DP
95507802033-09-18DS, DPU-1995, U-3055
98147082033-09-18DP
85247332031-04-03DS, DP
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX16: Deutetrabenazine
HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Huntington diseaseD006816G10212——4
Tardive dyskinesiaD000071057G24.01—13——3
ChoreaD002819EFO_0004152G25.5——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Dystonic disordersD020821G2411———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tourette syndromeD005879EFO_0004895F95.21————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDUTETRABENAZINE
INNdeutetrabenazine
Description
Austedo (dutetrabenazine) is a small molecule pharmaceutical. Dutetrabenazine was first approved as Austedo on 2017-04-03.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
[2H]C([2H])([2H])Oc1cc2c(cc1OC([2H])([2H])[2H])C1CC(=O)C(CC(C)C)CN1CC2
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3137326
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDP341G6W9NB (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Austedo - Teva
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 350 documents
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Safety
Black-box Warning
Black-box warning for: Austedo
Adverse Events
Top Adverse Reactions
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2,069 adverse events reported
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