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Last Updated: June 29, 2022

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 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

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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
Drug patent expirations by year for QELBREE
Drug Prices for QELBREE

See drug prices for QELBREE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for QELBREE
Generic Entry Date for QELBREE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Anatomical Therapeutic Chemical (ATC) Classes for QELBREE

US Patents and Regulatory Information for QELBREE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QELBREE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Formulations of viloxazine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of viloxazine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Formulations of viloxazine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting QELBREE

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-002 Apr 2, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-003 Apr 2, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-002 Apr 2, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Patent: 17206245
Estimated Expiration: See Plans and Pricing

Patent: 19216707
Estimated Expiration: See Plans and Pricing

Patent: 20233746
Estimated Expiration: See Plans and Pricing

Canada

Patent: 64088
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12074
Estimated Expiration: See Plans and Pricing

Japan

Patent: 90100
Estimated Expiration: See Plans and Pricing

Patent: 10093
Estimated Expiration: See Plans and Pricing

Patent: 32973
Estimated Expiration: See Plans and Pricing

Patent: 15506980
Estimated Expiration: See Plans and Pricing

Patent: 18090601
Estimated Expiration: See Plans and Pricing

Patent: 19123736
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6727
Estimated Expiration: See Plans and Pricing

Patent: 14009528
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Japan 2019123736 ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE) See Plans and Pricing
Japan 2015506980 ビロキサジンの緩和放出製剤 See Plans and Pricing
Australia 2020233746 Modified release formulations of viloxazine See Plans and Pricing
Japan 6832973 See Plans and Pricing
Australia 2017206245 Modified release formulations of viloxazine See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Boehringer Ingelheim
Dow
AstraZeneca
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.