NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
3/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELLBUTRIN XL is an extended-release oral tablet formulation of bupropion hydrochloride, an atypical antidepressant that increases dopamine and norepinephrine availability in the central nervous system. Approved in 2003, it is indicated for major depressive disorder and seasonal affective disorder. The mechanism differs from SSRIs, making it a valuable option for patients with sexual dysfunction or fatigue.
$77MPart D
LOE ApproachingProduct is in LOE-approaching phase with significant but declining market presence; commercial teams will focus on generic transition strategy and retained market share defense.
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 (9)
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
Started Jan 2024
8,600 enrolled
Obesity
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Extended-release Bupropion Hydrochloride Tablets in Chinese Healthy Volunteers
Started May 2016
16 enrolled
Depressive Disorder, Major
Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder
Started Feb 2015
534 enrolled
Depressive Disorder, Major
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
Started Nov 2010
50 enrolled
Depressive Disorder, Major
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
Started Jan 2010
8 enrolled
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.