NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Drug data last refreshed 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WELLBUTRIN SR is an extended-release oral tablet containing bupropion hydrochloride, an atypical antidepressant approved by the FDA in 1996. It is primarily indicated for major depressive disorder and works as a norepinephrine-dopamine reuptake inhibitor (NDRI), distinguishing it from SSRIs and other mechanisms. The extended-release formulation enables once or twice-daily dosing for improved patient compliance.
$6MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with modest Part D utilization, indicating a small and shrinking commercial footprint requiring defensive strategies.
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 (5)
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
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions
Started Jan 2010
8 enrolled
Depressive Disorder
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
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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.