Viloxazine hydrochloride - Generic Drug Details

What are the generic drug sources for viloxazine hydrochloride and what is the scope of patent protection?

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 nineteen patent family members in seven countries.

One supplier is listed for this compound.

Summary for viloxazine hydrochloride

International Patents:	19
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	10
Patent Applications:	267
What excipients (inactive ingredients) are in viloxazine hydrochloride?	viloxazine hydrochloride excipients list
DailyMed Link:	viloxazine hydrochloride at DailyMed

Recent Clinical Trials for viloxazine hydrochloride

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

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

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

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			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
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	211964-003	Apr 2, 2021		RX	Yes	Yes			Y

International Patents for viloxazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2459322
Japan	6510093
Mexico	356727	FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Australia	2020233746	Modified release formulations of viloxazine
Japan	2018090601	ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Japan	2015506980	ビロキサジンの緩和放出製剤