Ledipasvir/Sofosbuvir — Competitive Intelligence Brief

Ledipasvir/Sofosbuvir (Ledipasvir/Sofosbuvir) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor). Area: Virology / Hepatology.

marketed Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor) HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase Virology / Hepatology Small molecule

Target snapshot

Ledipasvir/Sofosbuvir (Ledipasvir/Sofosbuvir) — Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Ledipasvir inhibits hepatitis C virus NS5A protein while sofosbuvir inhibits the viral NS5B polymerase, together blocking HCV replication.

Comparator set (5 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ledipasvir/Sofosbuvir TARGET	Ledipasvir/Sofosbuvir	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor)	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Combined therapy LDV and SOF	Combined therapy LDV and SOF	Yassin Abdelghaffar Charity Center for Liver Disease and Research	marketed	Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor)	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Daclinza and Sunvepra	Daclinza and Sunvepra	Pusan National University Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Daclatasvir + Sofosbuvir	Daclatasvir + Sofosbuvir	Federal University of São Paulo	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
Ledipasvir and sofosbuvir	Ledipasvir and sofosbuvir	National Taiwan University Hospital	marketed	Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor)	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
D+Z	D+Z	Sequential Medicine Ltd	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor) class)

1. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · 1 drug in this class
2. National Taiwan University Hospital · 1 drug in this class
3. Yassin Abdelghaffar Charity Center for Liver Disease and Research · 1 drug in this class