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deutetrabenazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.34 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 5.405 | High | 0.85 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.059 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 38.194 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 37.757 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 13.380 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 28.470 | % | High | 1 |
| herg | hERG pIC50 | 4.899 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 20.606 | uL/min/10^6 cells | High | 0.85 |
| hlm-clint | Human liver microsomal intrinsic clearance | 176.198 | uL/min/mg protein | High | 0.85 |
| hppb | Human plasma protein binding (% unbound) | 9.960 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 48 | |||
| kinase-selectivity-class | AXL,EIF2AK3,GRK2 | 3 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.729 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 97.949 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 12.180 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 2.472 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 25.610 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 177.419 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 62.670 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.160 | % | High | 0.85 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 270.396 | uM | High | 1 |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 134.35 | 30.55 | 48 | 2704 | 36486 | 90589209 |
| Tremor | 122.50 | 30.55 | 69 | 2683 | 153104 | 90472591 |
| Death | 116.86 | 30.55 | 102 | 2650 | 456449 | 90169246 |
| Depression | 99.34 | 30.55 | 78 | 2674 | 300523 | 90325172 |
| Tardive dyskinesia | 83.49 | 30.55 | 25 | 2727 | 10905 | 90614790 |
| Suicidal ideation | 77.75 | 30.55 | 40 | 2712 | 73815 | 90551880 |
| Drug ineffective | 66.16 | 30.55 | 135 | 2617 | 1384163 | 89241532 |
| Parkinsonism | 65.23 | 30.55 | 22 | 2730 | 14043 | 90611652 |
| Living in residential institution | 64.46 | 30.55 | 12 | 2740 | 666 | 90625029 |
| Drug titration error | 63.08 | 30.55 | 13 | 2739 | 1224 | 90624471 |
| Drooling | 55.50 | 30.55 | 15 | 2737 | 4531 | 90621164 |
| Hospitalisation | 55.02 | 30.55 | 39 | 2713 | 128061 | 90497634 |
| Therapy cessation | 54.20 | 30.55 | 25 | 2727 | 36336 | 90589359 |
| Product use issue | 52.53 | 30.55 | 57 | 2695 | 329862 | 90295833 |
| Somnolence | 51.73 | 30.55 | 46 | 2706 | 209038 | 90416657 |
| Therapy change | 38.51 | 30.55 | 13 | 2739 | 8309 | 90617386 |
| Akathisia | 31.17 | 30.55 | 12 | 2740 | 11147 | 90614548 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Death | 76.43 | 44.79 | 80 | 1164 | 471105 | 42148986 |
| Product use issue | 72.34 | 44.79 | 38 | 1206 | 76713 | 42543378 |
| Parkinsonism | 51.49 | 44.79 | 17 | 1227 | 10606 | 42609485 |
| Hospitalisation | 51.29 | 44.79 | 30 | 1214 | 74300 | 42545791 |
| Depression | 47.10 | 44.79 | 33 | 1211 | 111330 | 42508761 |
| Drug titration error | 45.13 | 44.79 | 9 | 1235 | 749 | 42619342 |
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 |
|---|---|---|---|---|---|---|
| Death | 194.25 | 34.22 | 155 | 2814 | 698714 | 109887616 |
| Product use issue | 138.12 | 34.22 | 92 | 2877 | 311603 | 110274727 |
| Tremor | 104.91 | 34.22 | 66 | 2903 | 202166 | 110384164 |
| Drug titration error | 102.40 | 34.22 | 20 | 2949 | 1627 | 110584703 |
| Dyskinesia | 96.27 | 34.22 | 40 | 2929 | 51406 | 110534924 |
| Tardive dyskinesia | 94.05 | 34.22 | 28 | 2941 | 13551 | 110572779 |
| Living in residential institution | 92.55 | 34.22 | 17 | 2952 | 994 | 110585336 |
| Depression | 84.47 | 34.22 | 69 | 2900 | 317266 | 110269064 |
| Parkinsonism | 80.53 | 34.22 | 28 | 2941 | 22159 | 110564171 |
| Suicidal ideation | 70.55 | 34.22 | 39 | 2930 | 93898 | 110492432 |
| Hospitalisation | 57.93 | 34.22 | 40 | 2929 | 142453 | 110443877 |
| Somnolence | 57.56 | 34.22 | 54 | 2915 | 297395 | 110288935 |
| Therapy cessation | 55.19 | 34.22 | 26 | 2943 | 44831 | 110541499 |
| Off label use | 54.64 | 34.22 | 122 | 2847 | 1500063 | 109086267 |
| Drooling | 50.63 | 34.22 | 15 | 2954 | 7124 | 110579206 |
| Therapy change | 41.66 | 34.22 | 14 | 2955 | 9983 | 110576347 |
| Tic | 41.53 | 34.22 | 11 | 2958 | 3482 | 110582848 |
| Drug ineffective | 39.67 | 34.22 | 109 | 2860 | 1520431 | 109065899 |
| Product use in unapproved indication | 37.97 | 34.22 | 53 | 2916 | 447324 | 110139006 |
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 |
Related Drugs by ATC class:
N07XX Other nervous system drugs 23 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 XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | 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 |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | 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 |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | 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 |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12016858 | 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 |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 18MG | AUSTEDO XR | TEVA | N216354 | July 1, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 30MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 36MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 42MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 48MG | AUSTEDO XR | TEVA | N216354 | May 29, 2024 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12589075 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 12599598 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
Orange Book exclusivity data (new drug applications)
None
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 |
| 4036562 | VANDF |
| C4277781 | UMLSCUI |
| CHEBI:755155 | CHEBI |
| CHEMBL3137326 | ChEMBL_ID |
| 73442840 | PUBCHEM_CID |
| DB12161 | DRUGBANK_ID |
| D10701 | KEGG_DRUG |
| 10069 | INN_ID |
| C000609690 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8707 | IUPHAR_LIGAND_ID |
| 733658007 | SNOMEDCT_US |
| 764363002 | SNOMEDCT_US |
| 255755 | MMSL |
| 32626 | MMSL |
| d08560 | MMSL |
| 017158 | NDDF |
| 1876905 | RXNORM |
| P341G6W9NB | INXIGHT DRUGS |
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 | 27 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-171 | TABLET, COATED | 9 mg | ORAL | NDA | 27 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-172 | TABLET, COATED | 12 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-470 | TABLET, FILM COATED, EXTENDED RELEASE | 6 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-471 | TABLET, FILM COATED, EXTENDED RELEASE | 12 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-472 | TABLET, FILM COATED, EXTENDED RELEASE | 24 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-473 | TABLET, FILM COATED, EXTENDED RELEASE | 30 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-474 | TABLET, FILM COATED, EXTENDED RELEASE | 36 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-475 | TABLET, FILM COATED, EXTENDED RELEASE | 42 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-476 | TABLET, FILM COATED, EXTENDED RELEASE | 48 mg | ORAL | NDA | 27 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-479 | TABLET, FILM COATED, EXTENDED RELEASE | 18 mg | ORAL | NDA | 27 sections |