Sovaldi
An oral direct-acting antiviral tablet used in combination to treat chronic hepatitis C.
Where Sofosbuvir is approved
All regulators →Of the three regulators tracked here, the first to approve Sofosbuvir was the US, on 6 Dec 2013. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Sofosbuvir patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Sofosbuvir, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 9 listed patents; the last listed expires 11 Jun 2031 (US 8618076, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 11 Jun 2031 (US 8618076, with paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Sofosbuvir
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Sofosbuvir works
All drug targets →- RNA-directed RNA polymerase inhibitor InhibitorChEMBL only
- COVID-19Phase 3
- HIV infectious diseasePhase 3
- HIV-1 infectionPhase 3
- Hepatic fibrosisPhase 3
- Beta-thalassemia majorPhase 3
- Cirrhosis of liverPhase 3
- Hepatitis B virus infectionPhase 3
- Hepatocellular carcinomaPhase 3
- Liver disorderPhase 3
- Chronic hepatitis B virus infectionPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1259059, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7368, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Sofosbuvir
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Sofosbuvir. 4 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C NICE TA507 | Optimised | 21 Feb 2018 | Current |
| Sofosbuvir–velpatasvir for treating chronic hepatitis C NICE TA430 | Optimised | 25 Jan 2017 | Current |
| Ledipasvir–sofosbuvir for treating chronic hepatitis C NICE TA363 | Optimised | 25 Nov 2015 | Current |
| Sofosbuvir for treating chronic hepatitis C NICE TA330 | Optimised | 25 Feb 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Sofosbuvir
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: SovaldiEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Sofosbuvir
- ChEMBL
- CHEMBL1259059
- DrugBank
- DB08934
- PubChem CID
- 45375808
- CAS number
- 1190307-88-0
- FDA UNII
- WJ6CA3ZU8B
- Wikidata
- Q2502747
- Wikipedia
- Sofosbuvir
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Sovaldi is used for
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. ( 1 ) Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. ( 1 ) Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2) , and Clinical Studies (14) ]: genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin genotype 2 or 3 infection without cirrhosis or wit…
How it works
12.1 Mechanism of Action Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.