NDAORALTABLETPriority Review
Approved
Nov 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
REVIA (naltrexone hydrochloride) by Teva is clinical pharmacology pharmacodynamic actions naltrexone is a pure opioid antagonist. First approved in 1984.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REVIA (naltrexone hydrochloride) is a pure opioid receptor antagonist oral tablet approved in 1984 for treating opioid and alcohol dependence. It works by competitively blocking opioid receptors, preventing the euphoric effects of opioids and reducing alcohol craving through modulation of the endogenous opioid system. The drug has no intrinsic abuse potential and does not produce tolerance or dependence.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling transition from brand defense to market-share stabilization and potential team right-sizing.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamic Actions Naltrexone is a pure opioid antagonist. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids. When coadministered with morphine, on a chronic basis, naltrexone blocks the physical…
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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.