COPEGUS
LOE ApproachingNDAORALTABLETPriority Review
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COPEGUS is an oral small-molecule antiviral approved by Roche in December 2002. The drug is indicated for chronic hepatitis C infection, typically used in combination with interferon-based regimens. It functions as a nucleoside analog that inhibits viral RNA replication in hepatitis C patients.
LOE Approaching
Declining
As LOE approaches, the brand team is likely transitioning to lifecycle management mode with reduced headcount and focus shifting to generic transition planning.
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 Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Started Sep 2015
552 enrolled
Hepatitis C Virus Infection
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
Started Apr 2013
61 enrolled
Hepatitis C, Chronic
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
Started Sep 2012
40 enrolled
Healthy Volunteer
A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Started Aug 2012
165 enrolled
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
Started Jul 2012
0Hepatitis 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.