Sofosbuvir + Daclatasvir — Competitive Intelligence Brief

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

phase 3 Direct-acting antiviral (DAA) combination HCV NS5B polymerase and HCV NS5A protein Virology / Hepatology Small molecule

Target snapshot

Sofosbuvir + Daclatasvir (Sofosbuvir + Daclatasvir) — Egyptian Liver Hospital. Sofosbuvir and daclatasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir + Daclatasvir TARGET	Sofosbuvir + Daclatasvir	Egyptian Liver Hospital	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and HCV NS5A protein
Sofosbuvir/Ledipasvir 24W	Sofosbuvir/Ledipasvir 24W	Iran Hepatitis Network	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and HCV NS5A protein
Sofosbuvir plus Ledipasvir	Sofosbuvir plus Ledipasvir	Almaza Military Fever Hospital	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and HCV NS5A protein
Sofosbuvir/Ledipasvir x 12 weeks	Sofosbuvir/Ledipasvir x 12 weeks	Medical University of South Carolina	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
Sofosbuvir and Velpatasvir	Sofosbuvir and Velpatasvir	Hannover Medical School	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
Zepatier plus Sofosbuvir	Zepatier plus Sofosbuvir	Massachusetts General Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A, NS3/4A protease, NS5B 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

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