WELLBUTRIN
LOE ApproachingNDAORALTABLETPriority Review
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 6h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELLBUTRIN is an oral small-molecule antidepressant approved in 1985, currently approaching loss of exclusivity. The drug's mechanism of action and specific indications are not detailed in available data, but it remains a foundational treatment in mental health therapeutics.
LOE Approaching
As LOE approaches, the WELLBUTRIN brand team will transition from growth-focused work to lifecycle management and potential generic defense strategies, likely resulting in smaller commercial teams.
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 (8)
A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks
Started Oct 2016
1 enrolled
Depressive Disorder, Major
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
Started Nov 2010
50 enrolled
Depressive Disorder, Major
A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects
Started Jan 2008
27 enrolled
Diabetes Mellitus, Type 2
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Started Feb 2007
33 enrolled
Depressive Disorder
Wellbutrin XL, Major Depressive Disorder and Breast Cancer
Started Sep 2005
25 enrolled
Breast CancerMajor 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.