QELBREE Drug Patent Profile

When do Qelbree patents expire, and what generic alternatives are available?

Qelbree is a drug marketed by Supernus Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has fifteen patent family members in six countries.

The generic ingredient in QELBREE is viloxazine hydrochloride. One supplier is listed for this compound. Additional details are available on the viloxazine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Qelbree

Qelbree will be eligible for patent challenges on April 2, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QELBREE

International Patents:	15
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Patent Applications:	3,559
Drug Prices:	Drug price information for QELBREE
What excipients (inactive ingredients) are in QELBREE?	QELBREE excipients list
DailyMed Link:	QELBREE at DailyMed

See drug prices for QELBREE

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for QELBREE

NDA:

211964

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.

Pharmacology for QELBREE

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 QELBREE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for QELBREE

QELBREE is protected by three US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QELBREE

FDA Regulatory Exclusivity protecting QELBREE

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	211964-001	Apr 2, 2021		RX	Yes	No
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	211964-001	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	211964-002	Apr 2, 2021		RX	Yes	No
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No			Y

International Patents for QELBREE

When does loss-of-exclusivity occur for QELBREE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

European Patent Office

Japan

Mexico

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QELBREE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013119794
Japan	2019123736	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
Australia	2020233746	Modified release formulations of viloxazine
Japan	6832973
Australia	2017206245	Modified release formulations of viloxazine