Treats chronic hepatitis C virus (HCV) infection as a component of a combination…. Sold as Sovaldi. Every FDA application for this active ingredient: 2 branded and 1 generic.
As of Nov 14, 2026, FDA lists 3 applications for Sofosbuvir (sold as Sovaldi), first approved Dec 6, 2013, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Sovaldi | Part D | $1.9M | -14% | 20 |
| AI-Powered Hepatitis C Single-Encounter Test-and-TreatHEPATITIS C (HCV) · Patrick Grace | Phase 4 | Not yet recruiting | Aug 28, 2026 |
| Treatment of CKD Patients With HCVHCV Infection ( Genotype 4) in CKD Patients · Tanta University | Phase 2 / Phase 3 | Not yet recruiting | Aug 18, 2026 |
| Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA TreatmentHepatitis C Virus (HCV) · Xiangya Hospital of Central South University | — | Active, not recruiting | May 4, 2026 |
| Combating Related Epidemics in HCVHIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV) · Duke University | Phase 4 | Not yet recruiting | Apr 30, 2026 |
| SVR12 in Genotype 3 HCV (F0-F2) Treated With RDV + SOFViral Hepatitis C · Center of target therapy | — | Active, not recruiting | Jan 5, 2026 |
| Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard StrategyHepatitis C Virus Infection · ANRS, Emerging Infectious Diseases | Phase 4 | Not yet recruiting | Aug 1, 2025 |
| C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCVHEPATITIS C VIRUS CHRONIC INFECTION, Hepatitis C, Chronic · Atea Pharmaceuticals, Inc. | Phase 3 | Active, not recruiting | Jun 25, 2025 |
| Implementing Low-Barrier HCV Treatment in a Jail SettingHEPATITIS C (HCV), Incarceration · Lifespan | Phase 4 | Recruiting | May 1, 2025 |
| Dec 6, 2013 | SovaldiNDA 204671 · New molecular entity | Gilead Sciences Inc | 12 | Marketed |
| Aug 28, 2019 | SovaldiNDA 212480 · New dosage form | Gilead Sciences Inc | 4 | Marketed |
| Jan 27, 2022 | SofosbuvirANDA 211353 | Teva Pharms USA Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
