viloxazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| alkaloids and organic bases | 2820 | 46817-91-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE. The mechanism of action of viloxazine in the treatment of ADHD is unclear; however, it is thought to be through inhibiting the reuptake of norepinephrine.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 85 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.73 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 4.10 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 78 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 2, 2021 | FDA | SUPERNUS PHARMS |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06AX09 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants |
| FDA MoA | N0000000102 | Norepinephrine Uptake Inhibitors |
| FDA EPC | N0000175695 | Norepinephrine Reuptake Inhibitor |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
| FDA MoA | N0000182139 | Cytochrome P450 2B6 Inhibitors |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| MeSH PA | D018663 | Adrenergic Agents |
| MeSH PA | D018759 | Adrenergic Uptake Inhibitors |
| MeSH PA | D000928 | Antidepressive Agents |
| MeSH PA | D018687 | Antidepressive Agents, Second-Generation |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D014179 | Neurotransmitter Uptake Inhibitors |
| MeSH PA | D011619 | Psychotropic Drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cataplexy and narcolepsy | indication | 193042000 | |
| Attention deficit hyperactivity disorder | indication | 406506008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.55 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 29, 2025 | NEW PATIENT POPULATION |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 29, 2025 | NEW PATIENT POPULATION |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 29, 2025 | NEW PATIENT POPULATION |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 2, 2026 | NEW CHEMICAL ENTITY |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 2, 2026 | NEW CHEMICAL ENTITY |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | April 2, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium-dependent noradrenaline transporter | Transporter | ANTAGONIST | IC50 | 6.70 | DRUG LABEL | DRUG LABEL | |||
| Sodium-dependent serotonin transporter | Transporter | Kd | 4.76 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Kd | 6.81 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 4.78 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 4.32 | CHEMBL | |||||
| Transporter | Transporter | Ki | 6.77 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D08673 | KEGG_DRUG |
| 35604-67-2 | SECONDARY_CAS_RN |
| 4025281 | VANDF |
| 4040491 | VANDF |
| C0042665 | UMLSCUI |
| CHEBI:94405 | CHEBI |
| CHEMBL251072 | ChEMBL_ID |
| CHEMBL306700 | ChEMBL_ID |
| CHEMBL250052 | ChEMBL_ID |
| DB09185 | DRUGBANK_ID |
| CHEMBL2106483 | ChEMBL_ID |
| D014745 | MESH_DESCRIPTOR_UI |
| 5666 | PUBCHEM_CID |
| 11502 | IUPHAR_LIGAND_ID |
| 3489 | INN_ID |
| 5I5Y2789ZF | UNII |
| 11196 | RXNORM |
| 39447 | MMSL |
| d09726 | MMSL |
| 004063 | NDDF |
| 004064 | NDDF |
| 1179159000 | SNOMEDCT_US |
| 349857003 | SNOMEDCT_US |
| 420070007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-131 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-131 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-131 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-132 | CAPSULE, EXTENDED RELEASE | 150 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-132 | CAPSULE, EXTENDED RELEASE | 150 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-132 | CAPSULE, EXTENDED RELEASE | 150 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-133 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-133 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | NDA | 33 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-133 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | NDA | 33 sections |