NDAORALPELLETSPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
7/8 — Comprehensive
Priority Review
HARVONI (ledipasvir and sofosbuvir) by Gilead Sciences is p-glycoprotein inhibitors [moa]. Approved for hepatitis c virus ns5a inhibitor [epc]. First approved in 2019.
Drug data last refreshed 13h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HARVONI is an oral fixed-dose combination of ledipasvir (NS5A inhibitor) and sofosbuvir (nucleotide analog) approved by FDA in August 2019 for treatment of hepatitis C virus infection. It works by inhibiting viral NS5A protein and RNA-dependent RNA polymerase, preventing HCV replication. This combination targets patients with chronic hepatitis C across multiple genotypes.
$55MPart D
PeakStable
6.6 years to LOEProduct is at peak commercial maturity with strong patent protection through 2033, suggesting sustained but not expanding team dynamics.
Mechanism of Action
P-Glycoprotein 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 (5)
Harvoni Treatment Porphyria Cutanea Tarda
Started Sep 2017
23 enrolled
Porphyria Cutanea TardaHepatitis C
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
Started Dec 2016
1,081 enrolled
Hepatitis C Virus
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
Started Feb 2016
71 enrolled
Hepatitis CMedication Adherence
Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
Started Jan 2016
14 enrolled
Hepatitis C, ChronicCirrhosis, Decompensated
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Started Nov 2015
3,294 enrolled
Hepatitis C
Worked on HARVONI 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.