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
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 |


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.
Pharmacology for QELBREE
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
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 |