qelbree Drug Patent Profile
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When do Qelbree patents expire, and when can generic versions of Qelbree launch?
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 |
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 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
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 | |||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-002 | Apr 2, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Supernus Pharms | QELBREE | viloxazine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964-003 | Apr 2, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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.
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 |
Canada | 2735934 | PROCEDE DE TRAITEMENT DE TROUBLE DEFICITAIRE DE L'ATTENTION AVEC HYPERACTIVITE (ADHD) (METHOD OF TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD)) | ⤷ Sign Up |
Australia | 2019216707 | Modified release formulations of viloxazine | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |