Details for New Drug Application (NDA): 211964
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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.
Pharmacology for NDA: 211964
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: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Apr 2, 2021 | TE: | 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 Up | Patent Expiration: | Sep 4, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
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