Wednesday, July 8, 2026

Drug profile · INN

sofosbuvir

sofosbuvir (EPCLUSA) is a rna-directed rna polymerase inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Antiinfectives for systemic use (J05) J05AX15
US status approved
Patents linked 2
Pipeline programs 10
News articles 1
Drug details — sofosbuvir
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
2
Programs
10
Data quality
0.89

Quick answer

sofosbuvir (EPCLUSA) is a rna-directed rna polymerase inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sofosbuvir
Brand EPCLUSA
Mechanism RNA-directed RNA polymerase inhibitor
Target RNA-directed RNA polymerase
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation PELLETS
ATC code J05AX15

Mechanism of action

RNA-directed RNA polymerase inhibitor

Primary target: RNA-directed RNA polymerase

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Recent coverage

Pipeline programs

  1. AT-01B-008 Phase 3 · Atea Pharmaceuticals · Chronic Hepatitis C Virus (HCV) Infection
  2. Sofosbuvir Phase 3 · Gilead Sciences Ireland · Chronic HCV Infection
  3. Sofosbuvir Phase 3 · Gilead Sciences Ireland · Hepatitis C
  4. Sofosbuvir Phase 2 · BRIGHT MINDS BIOSCIENCES · Hepatitis C, Chronic
  5. Telaprevir and Sofosbuvir Phase 2 · Vertex Pharmaceuticals (Australia) · Hepatitis C, Chronic
  6. Harvoni (Fixed dose combination ledipasvir/sofosbuvir) Approved · BRIGHT MINDS BIOSCIENCES · Hepatitis C
  7. Ledipasvir 90mg/Sofosbuvir 400 mg Approved · Chinese Academy of · Hepatocellular Carcinoma
  8. Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] Approved · BRIGHT MINDS BIOSCIENCES · HEPATITIS C (HCV)

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. darunavir Antiinfectives for systemic use (J05)
  6. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)
  1. US 10676498

    Processes for the preparation of sofosbuvir and intermediates thereof

    Expires Mon Jun 04 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10214553

    Solid state forms of sofosbuvir

    Expires Mon Feb 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is sofosbuvir?

sofosbuvir (EPCLUSA) is a rna-directed rna polymerase inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sofosbuvir?

EPCLUSA is a marketed brand name for sofosbuvir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sofosbuvir?

sofosbuvir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.