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Drug ReportsDeutetrabenazine
Deutetrabenazine
Austedo (deutetrabenazine) is a small molecule pharmaceutical. Deutetrabenazine was first approved as Austedo on 2017-04-03. It is used to treat chorea and tardive dyskinesia in the USA.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Austedo, Deutetrabenazine
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
8 products, RLD, RS
AUSTEDOTevaN-208082 RX2017-04-03
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
austedoNew Drug Application2022-05-17
austedo austedo xrNew Drug Application2024-07-01
Indications
FDA
EMA
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
118132322038-03-15DP
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
116665662033-09-18DP
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
No data
Drug
General
Drug common nameDeutetrabenazine
INNdeutetrabenazine
Description
Austedo (dutetrabenazine) is a small molecule pharmaceutical. Dutetrabenazine was first approved as Austedo on 2017-04-03.
Classification
Small molecule
Drug class
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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-ID1392826-25-3
RxCUI
ChEMBL IDCHEMBL3137326
ChEBI ID
PubChem CID45255840
DrugBank
UNII IDP341G6W9NB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Austedo Teva
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Estimated US medical usage
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Austedo, Austedo austedo xr
Adverse Events
0 adverse events reported
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