Generic Qelbree Availability
Last updated on Apr 10, 2025.
Qelbree is a brand name of viloxazine, approved by the FDA in the following formulation(s):
QELBREE (viloxazine hydrochloride - capsule, extended release;oral)
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Manufacturer: SUPERNUS PHARMS
Approval date: April 2, 2021
Strength(s): EQ 100MG BASE [RLD], EQ 150MG BASE [RLD], EQ 200MG BASE [RLD]
Is there a generic version of Qelbree available?
No. There is currently no therapeutically equivalent version of Qelbree available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qelbree. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Patent 11,324,753
Issued: May 10, 2022
Inventor(s): Breder; Christopher D.
Assignee(s): Supernus Pharmaceuticals, Inc. (Rockville, MD)The invention comprises a method for treatment of ADHD or ADHD-related disorders by a pharmaceutical agent exhibiting combined serotonergic or noradrenergic reuptake transporters and monoamine receptor activity.
Patent expiration dates:
- September 4, 2029✓
- September 4, 2029
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Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Patent 11,458,143
Issued: October 4, 2022
Inventor(s): Breder; Christopher D.
Assignee(s): Supernus Pharmaceuticals, Inc. (Rockville, MD)The invention comprises a method for treatment of ADHD or ADHD-related disorders by a pharmaceutical agent exhibiting combined serotonergic or noradrenergic reuptake transporters and monoamine receptor activity.
Patent expiration dates:
- September 4, 2029✓
- September 4, 2029
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Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Patent 12,121,523
Issued: October 22, 2024
Inventor(s): Breder; Christopher D.
Assignee(s): Supernus Pharmaceuticals, Inc. (Rockville, MD)The invention comprises a method for treatment of ADHD or ADHD-related disorders by a pharmaceutical agent exhibiting combined serotonergic or noradrenergic reuptake transporters and monoamine receptor activity.
Patent expiration dates:
- September 4, 2029✓
- September 4, 2029
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Formulations of viloxazine
Patent 9,358,204
Issued: June 7, 2016
Inventor(s): Vieira Michael L. & Huang Austin B. & Bhatt Padmanabh P.
Assignee(s): Supernus Pharmaceuticals, Inc.Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.
Patent expiration dates:
- February 7, 2033✓
- February 7, 2033
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Formulations of viloxazine
Patent 9,603,853
Issued: March 28, 2017
Inventor(s): Vieira Michael L. & Huang Austin B. & Bhatt Padmanabh P.
Assignee(s): Supernus Pharmaceuticals, Inc.Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.
Patent expiration dates:
- February 7, 2033✓
- February 7, 2033
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Formulations of viloxazine
Patent 9,662,338
Issued: May 30, 2017
Inventor(s): Vieira Michael L. & Huang Austin B. & Bhatt Padmanabh P.
Assignee(s): Supernus Pharmaceuticals, Inc.Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.
Patent expiration dates:
- April 2, 2035✓
- April 2, 2035
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- April 29, 2025 - NEW PATIENT POPULATION
- April 2, 2026 - NEW CHEMICAL ENTITY
More about Qelbree (viloxazine)
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- FDA approval history
- Drug class: adrenergic uptake inhibitors for ADHD
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Patient resources
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.