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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
Molfile Inchi Smiles Synonyms: viloxazine hydrochloride viloxazine emovit viloxazin viloxazine HCl ICI 58,834 ICI 58834	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. Molecular weight: 237.30 Formula: C13H19NO3 CLOGP: 1.56 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 39.72 ALOGS: -2.28 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

viloxazine hydrochloride
viloxazine
emovit
viloxazin
viloxazine HCl
ICI 58,834
ICI 58834

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.

Molecular weight: 237.30
Formula: C13H19NO3
CLOGP: 1.56
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 39.72
ALOGS: -2.28
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.20	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	85 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	78 mg/mL	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	4.10 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	0.73 L/kg	Lombardo F, Berellini G, Obach RS

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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:

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Source	Code	Description
ATC	N06AX09	NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants
FDA EPC	N0000175695	Norepinephrine Reuptake Inhibitor
FDA MoA	N0000000102	Norepinephrine Uptake Inhibitors
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

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Cataplexy and narcolepsy	indication	193042000
Attention deficit hyperactivity disorder	indication	406506008

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🐶 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)

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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 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	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 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	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 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)

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Orange Book exclusivity data (new drug applications)

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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 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 29, 2025	NEW PATIENT POPULATION
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 29, 2025	NEW PATIENT POPULATION
EQ 200MG BASE	QELBREE	SUPERNUS PHARMS	N211964	April 2, 2021	RX	CAPSULE, EXTENDED RELEASE	ORAL	April 2, 2026	NEW CHEMICAL ENTITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	ANTAGONIST	IC50	6.70	DRUG LABEL	DRUG LABEL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Kd	4.76	CHEMBL
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Kd	6.81	CHEMBL
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	4.78	CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	4.32	CHEMBL
Transporter	Transporter		Q9WTR4_RAT		Ki	6.77	CHEMBL

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External reference:

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ID	Source
004063	NDDF
004064	NDDF
11196	RXNORM
11502	IUPHAR_LIGAND_ID
1179159000	SNOMEDCT_US
3489	INN_ID
349857003	SNOMEDCT_US
35604-67-2	SECONDARY_CAS_RN
39447	MMSL
4025281	VANDF

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Pharmaceutical products:

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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

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