EXVIERA — Competitive Intelligence Brief

EXVIERA (EXVIERA) 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, NS5B, NS3/4A protease Virology / Hepatology Small molecule

Target snapshot

EXVIERA (EXVIERA) — HaEmek Medical Center, Israel. EXVIERA is a direct-acting antiviral (DAA) combination therapy that inhibits hepatitis C virus (HCV) NS5A and NS5B proteins to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
EXVIERA TARGET	EXVIERA	HaEmek Medical Center, Israel	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A, NS5B, NS3/4A protease
sofosbubir/velpatasvir/voxilaprevir	sofosbubir/velpatasvir/voxilaprevir	Partners in Health	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, NS5A protein, 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
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
EBR/GZR (elbasvir/grazoprevir)	EBR/GZR (elbasvir/grazoprevir)	University of Florida	marketed	Direct-acting antiviral (DAA) combination; NS5A inhibitor + NS3/4A protease inhibitor	Hepatitis C virus NS5A protein and NS3/4A serine protease
Sofosbuvir and Daclatasvir for 24 weeks	Sofosbuvir and Daclatasvir for 24 weeks	ANRS, Emerging Infectious Diseases	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B RNA polymerase and HCV 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