deutetrabenazine 🐢 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5226 1392826-25-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • deutetrabenazine
  • austedo
  • SD-809
  • SD 809
The precise mechanism by which deutetrabenazine exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (alpha-dihydrotetrabenazine [HTBZ] and beta-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
  • Molecular weight: 323.47
  • Formula: C19H27NO3
  • CLOGP: 3.27
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 38.77
  • ALOGS: -2.94
  • ROTB: 4

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 3, 2017 FDA TEVA PHARMS USA INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyskinesia 71.25 40.35 25 975 27836 50576288
Depression 69.27 40.35 42 958 165381 50438743
Therapy cessation 46.67 40.35 18 982 25993 50578131

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyskinesia 55.41 39.60 21 918 39367 64458426
Depression 48.13 39.60 31 908 183260 64314533
Therapy cessation 40.94 39.60 16 923 32473 64465320

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N07XX16 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
OTHER NERVOUS SYSTEM DRUGS
Other nervous system drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Huntington's chorea indication 58756001 DOID:12858
Tardive dyskinesia indication 102449007




🐢 Veterinary Drug Use

None

🐢 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.01 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 A METHOD OF TREATING HUNTINGTONS CHOREA
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 TREATMENT OF TARDIVE DYSKINESIA
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 A METHOD OF TREATING HUNTINGTONS CHOREA
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 TREATMENT OF TARDIVE DYSKINESIA
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 A METHOD OF TREATING HUNTINGTONS CHOREA
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 9550780 Sept. 18, 2033 TREATMENT OF TARDIVE DYSKINESIA
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 10959996 March 7, 2036 A METHOD OF TREATING HUNTINGTONS CHOREA
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 10959996 March 7, 2036 A METHOD OF TREATING HUNTINGTONS CHOREA
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 10959996 March 7, 2036 A METHOD OF TREATING HUNTINGTONS CHOREA
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 A METHOD OF TREATING HUNTINGTONS CHOREA
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 TREATMENT OF TARDIVE DYSKINESIA
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 A METHOD OF TREATING HUNTINGTONS CHOREA
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 TREATMENT OF TARDIVE DYSKINESIA
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 A METHOD OF TREATING HUNTINGTONS CHOREA
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL 11179386 March 15, 2038 TREATMENT OF TARDIVE DYSKINESIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2022 NEW CHEMICAL ENTITY
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2022 NEW CHEMICAL ENTITY
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2022 NEW CHEMICAL ENTITY
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2022 PEDIATRIC EXCLUSIVITY
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2022 PEDIATRIC EXCLUSIVITY
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2022 PEDIATRIC EXCLUSIVITY
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2024 TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2024 TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL April 3, 2024 TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL June 24, 2024 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL June 24, 2024 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL June 24, 2024 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2024 PEDIATRIC EXCLUSIVITY
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2024 PEDIATRIC EXCLUSIVITY
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Oct. 3, 2024 PEDIATRIC EXCLUSIVITY
12MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Dec. 24, 2024 PEDIATRIC EXCLUSIVITY
6MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Dec. 24, 2024 PEDIATRIC EXCLUSIVITY
9MG AUSTEDO TEVA BRANDED PHARM N208082 April 3, 2017 RX TABLET ORAL Dec. 24, 2024 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Synaptic vesicular amine transporter Transporter INHIBITOR UNKNOWN DRUG LABEL

External reference:

IDSource
P341G6W9NB UNII
C4277781 UMLSCUI
CHEMBL3137326 ChEMBL_ID
73437646 PUBCHEM_CID
DB12161 DRUGBANK_ID
D10701 KEGG_DRUG
8707 IUPHAR_LIGAND_ID
1876905 RXNORM
255755 MMSL
32626 MMSL
d08560 MMSL
733658007 SNOMEDCT_US
764363002 SNOMEDCT_US
4036562 VANDF
017158 NDDF
C000609690 MESH_SUPPLEMENTAL_RECORD_UI
10069 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-170 TABLET, COATED 6 mg ORAL NDA 28 sections
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-170 TABLET, COATED 6 mg ORAL NDA 28 sections
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-171 TABLET, COATED 9 mg ORAL NDA 28 sections
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-171 TABLET, COATED 9 mg ORAL NDA 28 sections
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-172 TABLET, COATED 12 mg ORAL NDA 28 sections
Austedo HUMAN PRESCRIPTION DRUG LABEL 1 68546-172 TABLET, COATED 12 mg ORAL NDA 28 sections