REBETOL
LOE ApproachingNDAORALCAPSULEPriority Review
Approved
Jun 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REBETOL is an oral capsule antiviral approved in 1998 by Merck & Co. The drug's specific mechanism of action and therapeutic indication cannot be confirmed from available data, but the oral capsule formulation suggests treatment for a systemic viral infection. Patients requiring this therapy likely represent a chronic disease population given its nearly 26-year market presence.
LOE Approaching
Product approaching loss of exclusivity signals transition planning; commercial teams likely focused on lifecycle extension, generic preparation, or transition support rather than growth initiatives.
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 (20)
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Started Nov 2015
554 enrolled
Hepatitis C
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)
Started Dec 2009
2 enrolled
Hepatitis C
An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)
Started Jan 2009
0Hepatitis C, ChronicHepatitis C
Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)
Started Dec 2007
332 enrolled
Hepatitis C, ChronicHepatitis C
Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
Started Nov 2007
442 enrolled
Hepatitis C, Chronic
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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.