Sofosbuvir Oral Product — Competitive Intelligence Brief

Sofosbuvir Oral Product (Sofosbuvir Oral Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleotide analog NS5B polymerase inhibitor. Area: Virology / Hepatology.

marketed Nucleotide analog NS5B polymerase inhibitor HCV NS5B RNA-dependent RNA polymerase Virology / Hepatology Small molecule

Target snapshot

Sofosbuvir Oral Product (Sofosbuvir Oral Product) — MTI University. Sofosbuvir is a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase that blocks viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir Oral Product TARGET	Sofosbuvir Oral Product	MTI University	marketed	Nucleotide analog NS5B polymerase inhibitor	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
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
Sofosbuvir-Ribavirin	Sofosbuvir-Ribavirin	Ain Shams University	marketed	Nucleotide polymerase inhibitor + nucleoside analog antiviral	HCV NS5B RNA-dependent RNA polymerase; ribavirin has multiple targets
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
D+Z	D+Z	Sequential Medicine Ltd	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

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 (Nucleotide analog NS5B polymerase inhibitor class)

1. MTI University · 1 drug in this class