AUVELITY (bupropion hydrochloride)
AUVELITY is indicated for the treatment of Major Depressive Disorder.
How AUVELITY Works
Auvelity works through a synergistic dual-action mechanism. Dextromethorphan serves as an uncompetitive NMDA receptor antagonist and a sigma-1 receptor agonist. Because dextromethorphan is normally rapidly metabolized, bupropion is included to competitively inhibit the CYP450 2D6 enzyme, significantly increasing and sustaining dextromethorphan plasma levels. Additionally, bupropion contributes to the antidepressant effect by inhibiting the neuronal reuptake of norepinephrine and dopamine.
Details
- Status
- Prescription
- First Approved
- 2022-08-18
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
AUVELITY Approval History
What AUVELITY Treats
1 indicationsAUVELITY is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
AUVELITY Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . AUVELITY is not approved for use in pediatric patients [see Use in Specific Populations (8.4)] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information fo...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . AUVELITY is not approved for use in pediatric patients [see Use in Specific Populations (8.4)] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. AUVELITY is not approved for use in pediatric patients. ( 5.1 , 8.4 )
AUVELITY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AUVELITY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05976646 | HM20027635 5UG1DA050207 | Ph 1, Ph 2 | completed | Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion |
| NCT04526210 results posted | ALXN1840-HV-103 | Ph 1 | completed | Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants |
| NCT03326128 | 1703346 | Ph 2 | terminated | High Dose Bupropion for Smoking Cessation - Pilot Study |
| NCT01574703 CATS results posted | A3051148 2011-005513-37, CATS | Ph 4 | completed | Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. |
| NCT01456936 EAGLES results posted | A3051123 2010-022914-15, EAGLES | Ph 4 | completed | Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders |
| NCT01635972 | 9766-CL-0044 | Ph 1 | completed | Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AUVELITY FDA Label Details
Indications & Usage
FDA Label (PDF)AUVELITY is indicated for the treatment of Major Depressive Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [se...
AUVELITY Patents & Exclusivity
Patents (130 active)
Pro Intelligence Preview
Deep insights for AUVELITY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 260 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.