QELBREE Drug Patent Profile
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Which patents cover Qelbree, and what generic alternatives are available?
Qelbree is a drug marketed by Supernus Pharms and is included in one NDA. There are six 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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Questions you can ask:
- What is the 5 year forecast for QELBREE?
- What are the global sales for QELBREE?
- What is Average Wholesale Price for QELBREE?
Summary for QELBREE
International Patents: | 21 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 1 |
Patent Applications: | 114 |
Drug Prices: | Drug price information for QELBREE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QELBREE |
What excipients (inactive ingredients) are in QELBREE? | QELBREE excipients list |
DailyMed Link: | QELBREE at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for QELBREE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Supernus Pharmaceuticals, Inc. | Phase 4 |
Pharmacology for QELBREE
US Patents and Regulatory Information for QELBREE
QELBREE is protected by six US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QELBREE is ⤷ Try for Free.
This potential generic entry date is based on patent 9,358,204.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 12,121,523 | ⤷ Try for Free | ⤷ Try for Free | ||||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-003 | Apr 2, 2021 | RX | Yes | Yes | 11,458,143 | ⤷ Try for Free | ⤷ Try for Free | ||||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-003 | Apr 2, 2021 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-001 | Apr 2, 2021 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-001 | Apr 2, 2021 | RX | Yes | No | 9,603,853 | ⤷ Try for Free | ⤷ Try for Free | ||||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-002 | Apr 2, 2021 | RX | Yes | No | 9,603,853 | ⤷ Try for Free | ⤷ Try for Free | ||||
>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: ⤷ Try for Free
Patent: 17206245
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Try for Free
Patent: 19216707
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Try for Free
Patent: 20233746
Patent: Modified release formulations of viloxazine
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 64088
Patent: FORMULATIONS A LIBERATION MODIFIEE DE VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 12074
Patent: FORMULATIONS À LIBÉRATION MODIFIÉE DE VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Try for Free
Patent: 33915
Patent: FORMULATIONS DE LIBERATION MODIFIÉE DU VILOXAZINE (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 90100
Estimated Expiration: ⤷ Try for Free
Patent: 10093
Estimated Expiration: ⤷ Try for Free
Patent: 32973
Estimated Expiration: ⤷ Try for Free
Patent: 15506980
Patent: ビロキサジンの緩和放出製剤
Estimated Expiration: ⤷ Try for Free
Patent: 18090601
Patent: ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Try for Free
Patent: 19123736
Patent: ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 6727
Patent: FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Estimated Expiration: ⤷ Try for Free
Patent: 14009528
Patent: FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 50875
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Canada | 2735934 | PROCEDE DE TRAITEMENT DE TROUBLE DEFICITAIRE DE L'ATTENTION AVEC HYPERACTIVITE (ADHD) (METHOD OF TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD)) | ⤷ Try for Free |
Japan | 2019123736 | ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE) | ⤷ Try for Free |
Spain | 2950875 | ⤷ Try for Free | |
Australia | 2019216707 | Modified release formulations of viloxazine | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2013119794 | ⤷ Try for Free | |
Japan | 2018090601 | ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Qelbree
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