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 six patents protecting this drug. Additional details are available on the QELBREE profile page.
The generic ingredient in QELBREE is viloxazine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the viloxazine hydrochloride profile page.
The generic ingredient in QELBREE is viloxazine hydrochloride. There is one drug master file entry for this compound. 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: | 6 |
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 | ||||||||
| Patent: | 11,324,753 | Patent Expiration: | Sep 4, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) | ||||||||
| Patent: | 11,458,143 | 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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