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QELBREE Drug Patent Profile

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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 five patents protecting this drug.

This drug has twenty-one patent family members in seven 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

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Summary for QELBREE

International Patents:	21
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1
Patent Applications:	110
Drug Prices:	Drug price information for QELBREE
What excipients (inactive ingredients) are in QELBREE?	QELBREE excipients list
DailyMed Link:	QELBREE at DailyMed

Drug patent expirations by year for QELBREE

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

Generic Entry Date for QELBREE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for QELBREE

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

Sponsor	Phase
Supernus Pharmaceuticals, Inc.	Phase 4

See all QELBREE clinical trials

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

US Patents and Regulatory Information for QELBREE

QELBREE is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QELBREE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Formulations of viloxazine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of viloxazine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Formulations of viloxazine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting QELBREE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

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

Patent: 13217013
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Sign Up

Patent: 17206245
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Sign Up

Patent: 19216707
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Sign Up

Patent: 20233746
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 64088
Patent: FORMULATIONS A LIBERATION MODIFIEE DE VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 12074
Patent: FORMULATIONS À LIBÉRATION MODIFIÉE DE VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Sign Up

Patent: 33915
Patent: FORMULATIONS DE LIBERATION MODIFIÉE DU VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 90100
Estimated Expiration: ⤷ Sign Up

Patent: 10093
Estimated Expiration: ⤷ Sign Up

Patent: 32973
Estimated Expiration: ⤷ Sign Up

Patent: 15506980
Patent: ビロキサジンの緩和放出製剤
Estimated Expiration: ⤷ Sign Up

Patent: 18090601
Patent: ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Sign Up

Patent: 19123736
Patent: ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 6727
Patent: FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Estimated Expiration: ⤷ Sign Up

Patent: 14009528
Patent: FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 50875
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Japan	6832973		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010028207		⤷ Sign Up
Japan	6510093		⤷ Sign Up
Australia	2013217013	Modified release formulations of viloxazine	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration