LDV/SOF FDC — Competitive Intelligence Brief

LDV/SOF FDC (LDV/SOF FDC) 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 protein and NS5B RNA-dependent RNA polymerase Virology / Hepatology Small molecule

Target snapshot

LDV/SOF FDC (LDV/SOF FDC) — HepNet Study House, German Liverfoundation. LDV/SOF is a fixed-dose combination of ledipasvir (NS5A inhibitor) and sofosbuvir (nucleotide NS5B polymerase inhibitor) that directly inhibits hepatitis C virus replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
LDV/SOF FDC TARGET	LDV/SOF FDC	HepNet Study House, German Liverfoundation	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and NS5B RNA-dependent RNA polymerase
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
Elbasvir/Grazoprevir	Elbasvir/Grazoprevir	University of Florence	marketed	Direct-acting antiviral (DAA) combination; NS5A inhibitor + NS3/4A protease inhibitor	HCV NS5A protein and HCV NS3/4A serine protease
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
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	Grazaoprevir/Elbasavir	The HIV Netherlands Australia Thailand Research Collaboration	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