NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
7/8 — Comprehensive
CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) by Azurity is components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Approved for combination with a reduced-calorie diet, increased physical activity to reduce excess body weight, maintain weight reduction long term in adults with obesity and 1 more indications. First approved in 2014.
Drug data last refreshed 13h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CONTRAVE is an oral extended-release tablet combining naltrexone (opioid antagonist) and bupropion (dopamine/norepinephrine reuptake inhibitor) approved in 2014 for chronic weight management. It works by targeting the hypothalamus (appetite regulation) and mesolimbic dopamine circuit (reward system), though the exact neurochemical mechanism driving weight loss remains incompletely understood. Indicated for use with reduced-calorie diet and increased physical activity in adults with obesity or overweight with comorbid conditions.
$0.002BPart D
Peak7.8 years to LOEProduct is at peak maturity with modest Part D utilization (1,707 claims in 2023), indicating a stable but niche market position with limited commercial expansion opportunities.
Mechanism of Action
components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the…
Worked on CONTRAVE at Azurity? Share your interview experience or compensation data (+7 days Pro)
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.