Sofosbuvir/Ledipasvir plus Ribavirin 12W — Competitive Intelligence Brief

Sofosbuvir/Ledipasvir plus Ribavirin 12W (Sofosbuvir/Ledipasvir plus Ribavirin 12W) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral. Area: Infectious Diseases.

phase 3 Direct-acting antiviral HCV NS5B polymerase, HCV NS5A protein Infectious Diseases Small molecule

Target snapshot

Sofosbuvir/Ledipasvir plus Ribavirin 12W (Sofosbuvir/Ledipasvir plus Ribavirin 12W) — Iran Hepatitis Network. Sofosbuvir/Ledipasvir plus Ribavirin works by inhibiting the HCV NS5B polymerase and NS5A protein, and also inhibiting the HCV RNA-dependent RNA polymerase, leading to the suppression of viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir/Ledipasvir plus Ribavirin 12W TARGET	Sofosbuvir/Ledipasvir plus Ribavirin 12W	Iran Hepatitis Network	phase 3	Direct-acting antiviral	HCV NS5B polymerase, HCV NS5A protein
Sofosbuvir/Velpatasvir + Ribavirin	Sofosbuvir/Velpatasvir + Ribavirin	Peking University People's Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, HCV NS5A protein
Sofosbuvir/Velpatasvir/Voxilaprevir	Sofosbuvir/Velpatasvir/Voxilaprevir	Peking University People's Hospital	marketed	Direct-acting antiviral (DAA) combination; NS5B polymerase inhibitor + NS5A inhibitor + NS3/4A protease inhibitor	HCV NS5B polymerase, HCV NS5A protein, HCV NS3/4A protease
Sofosbuvir/Ledipasvir plus Ribavirin 24W	Sofosbuvir/Ledipasvir plus Ribavirin 24W	Iran Hepatitis Network	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, HCV NS5A protein
Administration of DAA-based treatment	Administration of DAA-based treatment	Ain Shams University	phase 3	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease, HCV NS5B polymerase, HCV NS5A protein (depending on specific DAA regimen)
Daclatasvir + Sofosbuvir	Daclatasvir + Sofosbuvir	Federal University of São Paulo	marketed	Direct-acting antiviral (DAA) combination	HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase
sofosbuvir/ledipasvir	sofosbuvir/ledipasvir	University of Texas Southwestern Medical Center	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 class)

1. Hospices Civils de Lyon · 1 drug in this class
2. Iran Hepatitis Network · 1 drug in this class
3. Qing XIe · 1 drug in this class
4. Sang Gyune Kim · 1 drug in this class