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Qelbree

(IR Viloxazine)

Small molecule

Supernus Pharmaceuticals, Inc.

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

Adult1 trial

Evaluation of Immediate-Release Viloxazine in Adults With ADHD

Completed· Supernus Pharmaceuticals, Inc. logo

Supernus Pharmaceuticals, Inc.·Phase 1/2·NCT01107496·52 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 2, 2021

QELBREE

NDA NDA211964

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for IR Viloxazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IR Viloxazine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211964). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Qelbree. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Supernus Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Supernus Pharmaceuticals, Inc.

Patent Landscape[4]

Patent Cliff

Sep 4, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12121523Sep 4, 2029

11458143Sep 4, 2029

11324753Sep 4, 2029

9603853Feb 7, 2033

9358204Feb 7, 2033

1 more patents

9662338Apr 2, 2035

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