Sofosbuvir plus Ledipasvir — Competitive Intelligence Brief

Sofosbuvir plus Ledipasvir (Sofosbuvir plus Ledipasvir) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral (DAA) combination. Area: Infectious Disease / Virology.

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

Target snapshot

Sofosbuvir plus Ledipasvir (Sofosbuvir plus Ledipasvir) — Almaza Military Fever Hospital. Sofosbuvir and ledipasvir 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 plus Ledipasvir TARGET	Sofosbuvir plus Ledipasvir	Almaza Military Fever 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 + Daclatasvir	Sofosbuvir + Daclatasvir	Egyptian Liver Hospital	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and HCV NS5A protein
Sofosbuvir and Velpatasvir	Sofosbuvir and Velpatasvir	Hannover Medical School	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
Post-transplant Grazoprevir and Elbasvir	Post-transplant Grazoprevir and Elbasvir	University of Maryland, Baltimore	marketed	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease and NS5A protein
Grazaoprevir/Elbasavir/RBV	Grazaoprevir/Elbasavir/RBV	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Direct-acting antiviral (DAA) combination; NS3/4A protease inhibitor + NS5A inhibitor + nucleoside analog	HCV NS3/4A protease; HCV NS5A protein; viral RNA polymerase
Grazoprevir/Elbasvir	Grazoprevir/Elbasvir	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	marketed	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease 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