APLENZIN (bupropion hydrobromide)
APLENZIN is indicated for the treatment of Major Depressive Disorder; Seasonal Affective Disorder.
How APLENZIN Works
The exact mechanism of action is unknown, though the drug's effects are presumed to be mediated by noradrenergic and dopaminergic mechanisms. It functions as a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine. Unlike some other classes of antidepressants, this medication does not inhibit monoamine oxidase or the reuptake of serotonin.
Details
- Status
- Prescription
- First Approved
- 2008-04-23
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
APLENZIN Approval History
What APLENZIN Treats
2 indicationsAPLENZIN is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Seasonal Affective Disorder
APLENZIN 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 ...
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. Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )
APLENZIN 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 APLENZIN
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02129751 | V01-BUPA-401 | Ph 4 | not yet recruiting | Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder |
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.
APLENZIN FDA Label Details
Indications & Usage
FDA Label (PDF)APLENZIN 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...
Pro Intelligence Preview
Deep insights for APLENZIN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 72 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.