CONTRAVE (bupropion hydrochloride)
CONTRAVE is indicated for the treatment of Major Depressive Disorder; Seasonal Affective Disorder.
How CONTRAVE Works
The exact mechanism of action for bupropion is unknown, but its therapeutic effects are presumed to be mediated by noradrenergic and dopaminergic pathways. The drug functions as a relatively weak inhibitor of the neuronal uptake of the neurotransmitters norepinephrine and dopamine. Unlike some other classes of antidepressants, it does not inhibit monoamine oxidase or the reuptake of serotonin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-10
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
CONTRAVE Approval History
What CONTRAVE Treats
2 indicationsCONTRAVE is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Seasonal Affective Disorder
CONTRAVE Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of s...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )
CONTRAVE 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 CONTRAVE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06809166 | 2023004 | Ph 4 | recruiting | Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity |
| NCT04499950 A-NEW results posted | IRB00223131 | Ph 2 | completed | Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study |
| NCT03431831 results posted | 0763-16-FB | Ph 4 | completed | Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic |
| 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.
CONTRAVE FDA Label Details
Indications & Usage
FDA Label (PDF)CONTRAVE is indicated for the treatment of Major Depressive Disorder; Seasonal Affective Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with...
CONTRAVE Patents & Exclusivity
Patents (18 active)
Pro Intelligence Preview
Deep insights for CONTRAVE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 18 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment