NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2008
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
1
Data completeness
6/8 — Strong
Drug data last refreshed 7h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APLENZIN is an extended-release oral tablet formulation of bupropion hydrobromide approved for major depressive disorder (MDD) and seasonal affective disorder (SAD). The mechanism of action is not fully understood but is presumed to involve noradrenergic and/or dopaminergic mechanisms through weak inhibition of neuronal reuptake of norepinephrine and dopamine. Unlike other antidepressants, bupropion does not inhibit serotonin reuptake or monoamine oxidase.
$0.02BPart D
LOE ApproachingPost-LOEWith less than one year until patent expiration, APLENZIN faces imminent generic competition in a market dominated by stronger competitors, signaling reduced team investment and commercial headcount optimization.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Started Jun 2026
246 enrolled
Major Depressive Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.