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Last Updated: November 29, 2024

Details for New Drug Application (NDA): 211964


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NDA 211964 describes QELBREE, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the QELBREE profile page.

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.
Summary for 211964
Tradename:QELBREE
Applicant:Supernus Pharms
Ingredient:viloxazine hydrochloride
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211964
Generic Entry Date for 211964*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 211964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964 NDA Supernus Pharmaceuticals, Inc 17772-131 17772-131-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-01)
QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964 NDA Supernus Pharmaceuticals, Inc 17772-131 17772-131-07 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:Apr 2, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 2, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 29, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Sign UpPatent Expiration:Sep 4, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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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.