Sofosbuvir and Daclatasvir for 24 weeks — Competitive Intelligence Brief

Sofosbuvir and Daclatasvir for 24 weeks (Sofosbuvir and Daclatasvir for 24 weeks) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral (DAA) combination. Area: Infectious Disease / Virology.

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

Target snapshot

Sofosbuvir and Daclatasvir for 24 weeks (Sofosbuvir and Daclatasvir for 24 weeks) — ANRS, Emerging Infectious Diseases. Sofosbuvir inhibits hepatitis C virus (HCV) NS5B RNA polymerase while daclatasvir inhibits NS5A protein, together blocking viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir and Daclatasvir for 24 weeks TARGET	Sofosbuvir and Daclatasvir for 24 weeks	ANRS, Emerging Infectious Diseases	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B RNA polymerase and HCV NS5A protein
LDV/SOF FDC	LDV/SOF FDC	HepNet Study House, German Liverfoundation	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and NS5B RNA-dependent RNA polymerase
Sofosbuvir, Ribavirin, and Stribild	Sofosbuvir, Ribavirin, and Stribild	Saint Michael's Medical Center	marketed	Direct-acting antiviral (DAA) combination; antiretroviral combination	HCV NS5B RNA polymerase; HIV integrase; HIV reverse transcriptase
sofosbubir/velpatasvir/voxilaprevir	sofosbubir/velpatasvir/voxilaprevir	Partners in Health	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, NS5A protein, NS3/4A protease
EXVIERA	EXVIERA	HaEmek Medical Center, Israel	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A, NS5B, NS3/4A protease
Sofosbuvir/Velpatasvir + Ribavirin	Sofosbuvir/Velpatasvir + Ribavirin	Peking University People's Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, HCV NS5A protein
SOF+RBV	SOF+RBV	Humanity and Health Research Centre	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B RNA polymerase; viral replication machinery

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