Sofosbuvir/Ledipasvir 24W — Competitive Intelligence Brief

Sofosbuvir/Ledipasvir 24W (Sofosbuvir/Ledipasvir 24W) 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/Ledipasvir 24W (Sofosbuvir/Ledipasvir 24W) — Iran Hepatitis Network. Sofosbuvir/Ledipasvir is a fixed-dose combination of a nucleotide polymerase inhibitor and a non-structural protein 5A inhibitor that blocks hepatitis C virus replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir/Ledipasvir 24W TARGET	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 + Daclatasvir	Sofosbuvir + Daclatasvir	Egyptian Liver Hospital	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B 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
sofosbubir/velpatasvir/voxilaprevir	sofosbubir/velpatasvir/voxilaprevir	Partners in Health	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, NS5A protein, NS3/4A protease
ABT450r-ABT267-ABT333 +/- Ribavirin	ABT450r-ABT267-ABT333 +/- Ribavirin	Ottawa Hospital Research Institute	marketed	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease, NS5A protein, NS5B polymerase
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

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