NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2008
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
1
Data completeness
8/8 — Comprehensive
APLENZIN (bupropion hydrobromide) by Bausch + Lomb is unknown, as is the case with other antidepressants. Approved for major depressive disorder (mdd), seasonal affective disorder (sad), defined by the diagnostic and 2 more indications. First approved in 2008.
Drug data last refreshed 10h ago · AI intelligence enriched 2w 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 Approaching0mo to 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
unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the…
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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.