Sofosbuvir/Ledipasvir x 12 weeks — Competitive Intelligence Brief

Sofosbuvir/Ledipasvir x 12 weeks (Sofosbuvir/Ledipasvir x 12 weeks) 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 NS5B polymerase and NS5A protein Virology/Hepatology Small molecule

Target snapshot

Sofosbuvir/Ledipasvir x 12 weeks (Sofosbuvir/Ledipasvir x 12 weeks) — Medical University of South Carolina. Sofosbuvir inhibits hepatitis C virus NS5B polymerase while ledipasvir inhibits NS5A protein, together blocking viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir/Ledipasvir x 12 weeks TARGET	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
Sofosbuvir / Velpatasvir	Sofosbuvir / Velpatasvir	Peking University First Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
sofosbuvir/velpatasvir crushed	sofosbuvir/velpatasvir crushed	Radboud University Medical Center	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
sofosbuvir/ledipasvir	sofosbuvir/ledipasvir	University of Texas Southwestern Medical Center	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	Ohio State University	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
sofosbubir/velpatasvir	sofosbubir/velpatasvir	Partners in Health	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