NDAORALTABLETPriority Review
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
Priority Review
EPCLUSA (velpatasvir and sofosbuvir) by Gilead Sciences is breast cancer resistance protein inhibitors [moa]. Approved for hepatitis c virus ns5a inhibitor [epc]. First approved in 2016.
Drug data last refreshed 5h ago · AI intelligence enriched 4w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPCLUSA is an oral fixed-dose combination of velpatasvir and sofosbuvir used to treat hepatitis C virus (HCV) infection across all genotypes. It works by inhibiting the NS5B polymerase, a critical viral replication enzyme, preventing the virus from copying itself. This all-oral, once-daily regimen represents a major shift from interferon-based therapies to direct-acting antivirals.
$877MPart D
PeakStable
7.7 years to LOEThe product maintains strong peak-stage revenue with 33.5K annual Part D claims, indicating a stable but mature franchise requiring efficient commercial execution and operational excellence.
Mechanism of Action
Breast Cancer Resistance Protein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
Started Feb 2018
25 enrolled
HIV-1-infectionHepatitis C, ChronicMethadone Dependence+6 more
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Started Jul 2014
106 enrolled
Hepatitis C Virus Infection
Why This Matters for Your Career
Worked on EPCLUSA at Gilead Sciences? 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.