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VILOXAZINE HYDROCHLORIDE
Viloxazine Hydrochloride is a marketed drug primarily indicated for the treatment of ADHD. Its key composition patent is set to expire in 2028, providing a period of exclusivity that supports its market position. The primary risk is the potential increase in competition following the patent expiry.
At a glance
| Generic name | VILOXAZINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2021 |
Approved indications
- Treatment of ADHD
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo . Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. In clinical trials, higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).
Common side effects
- Somnolence
- Decreased appetite
- Fatigue
- Nausea
- Vomiting
- Insomnia
- Irritability
- Headache
- Dry mouth
- Constipation
- Tachycardia
Key clinical trials
- Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms (PHASE4)
- Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD (PHASE4)
- National Pregnancy Registry for Psychiatric Medications
- Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) (PHASE3)
- Evaluation of Immediate-Release Viloxazine in Adults With ADHD (PHASE1, PHASE2)
- Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women (PHASE4)
- Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD (PHASE4)
- Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VILOXAZINE HYDROCHLORIDE CI brief — competitive landscape report
- VILOXAZINE HYDROCHLORIDE updates RSS · CI watch RSS