Viloxazine hydrochloride - Generic Drug Details

What are the generic sources for viloxazine hydrochloride and what is the scope of freedom to operate?

Viloxazine hydrochloride is the generic ingredient in one branded drug marketed by Supernus Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Viloxazine hydrochloride has twenty-one patent family members in seven countries.

One supplier is listed for this compound.

Summary for viloxazine hydrochloride

International Patents:	21
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	12
Patent Applications:	272
What excipients (inactive ingredients) are in viloxazine hydrochloride?	viloxazine hydrochloride excipients list
DailyMed Link:	viloxazine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for viloxazine hydrochloride

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for viloxazine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Apnimed	Phase 2
Supernus Pharmaceuticals, Inc.	Phase 4
Supernus Pharmaceuticals, Inc.	Phase 3

See all viloxazine hydrochloride clinical trials

Pharmacology for viloxazine hydrochloride

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Norepinephrine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for viloxazine hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for viloxazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-002	Apr 2, 2021		RX	Yes	No
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No			Y
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No

International Patents for viloxazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2459322
European Patent Office	4233915	FORMULATIONS DE LIBERATION MODIFIÉE DU VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Japan	6290100
Mexico	2014009528	FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Australia	2019216707	Modified release formulations of viloxazine
European Patent Office	2341912	PROCÉDÉ DE TRAITEMENT DE TROUBLE DÉFICITAIRE DE L ATTENTION AVEC HYPERACTIVITÉ (ADHD) (METHOD OF TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD))
Japan	2019123736	ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)