Daclatasvir + Sofosbuvir — Competitive Intelligence Brief

Daclatasvir + Sofosbuvir (Daclatasvir + Sofosbuvir) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral (DAA) combination. Area: Virology / Hepatology.

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

Target snapshot

Daclatasvir + Sofosbuvir (Daclatasvir + Sofosbuvir) — Federal University of São Paulo. Daclatasvir and sofosbuvir work together to inhibit hepatitis C virus (HCV) replication by blocking the NS5A protein and the NS5B RNA polymerase, respectively.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Daclatasvir + Sofosbuvir TARGET	Daclatasvir + Sofosbuvir	Federal University of São Paulo	marketed	Direct-acting antiviral (DAA) combination	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
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
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
Ledipasvir/Sofosbuvir	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
Sofosbuvir and Velpatasvir	Sofosbuvir and Velpatasvir	Hannover Medical School	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein

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 (DAA) combination class)

1. Massachusetts General Hospital · 3 drugs in this class
2. Egyptian Liver Hospital · 3 drugs in this class
3. Hannover Medical School · 2 drugs in this class
4. University of Maryland, Baltimore · 2 drugs in this class
5. Iran Hepatitis Network · 2 drugs in this class
6. Partners in Health · 2 drugs in this class
7. HaEmek Medical Center, Israel · 1 drug in this class
8. Almaza Military Fever Hospital · 1 drug in this class
9. Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · 1 drug in this class
10. Federal University of São Paulo · 1 drug in this class