deutetrabenazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5226 | 1392826-25-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 3, 2017 | FDA | TEVA PHARMS USA INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Tardive dyskinesia | 101.34 | 41.54 | 25 | 1114 | 8006 | 56282922 |
| Dyskinesia | 92.86 | 41.54 | 31 | 1108 | 29077 | 56261851 |
| Depression | 77.66 | 41.54 | 47 | 1092 | 180070 | 56110858 |
| Therapy cessation | 48.95 | 41.54 | 19 | 1120 | 27245 | 56263683 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Dyskinesia | 75.83 | 38.95 | 27 | 1044 | 41047 | 70886326 |
| Tardive dyskinesia | 63.71 | 38.95 | 17 | 1054 | 9912 | 70917461 |
| Depression | 54.42 | 38.95 | 35 | 1036 | 198939 | 70728434 |
| Therapy cessation | 43.30 | 38.95 | 17 | 1054 | 33659 | 70893714 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX16 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.01 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | 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 | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | 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 | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Synaptic vesicular amine transporter | Transporter | INHIBITOR | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| P341G6W9NB | UNII |
| C4277781 | UMLSCUI |
| CHEMBL3137326 | ChEMBL_ID |
| 6018 | PUBCHEM_CID |
| DB12161 | DRUGBANK_ID |
| D10701 | KEGG_DRUG |
| 10069 | INN_ID |
| 8707 | IUPHAR_LIGAND_ID |
| 255755 | MMSL |
| 32626 | MMSL |
| d08560 | MMSL |
| 017158 | NDDF |
| 733658007 | SNOMEDCT_US |
| 764363002 | SNOMEDCT_US |
| 4036562 | VANDF |
| C000609690 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1876905 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |