Prescription medicine
Sofosbuvir Brand names: Sovaldi
Sofosbuvir (Sovaldi) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc.); the NDA 204671 record on Drugs@FDA; every sofosbuvir label on DailyMed.
Highlights of the record
FDA label of December 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV.
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ]. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Used for
From the label: indications and usageSOVALDI 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.
Forms and strengths
- 150 mg
- 200 mg
- 400 mg
Pellet; film-coated tablet.
On the market
- Earliest approval on file
- December 6, 2013 Sovaldi, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 27, 2022; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 11, 2031 Sovaldi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19,615 through July 30, 2026
What is sofosbuvir used for?
From the label: indications and usageSOVALDI 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. […]
Conditions named in the indications of sofosbuvir's FDA labels, with every medicine labeled for each:
From other sofosbuvir labelsHepatitis C: 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 …
FDA pharmacologic class: Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor.
Source: FDA drug label (Sovaldi), Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), via openFDA; the full label on DailyMed
What does the patient leaflet for sofosbuvir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SOVALDI?SOVALDI can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with SOVALDI, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with SOVALDI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking SOVALDI. For more information about side effects, see the section " What are the possible side effects of SOVALDI? " What is SOVALDI? SOVALDI is a prescription medicine used with other antiviral medicines to treat adults with chronic (lasting a long time) hepatitis C virus (HCV): genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis in combination with peginterferon alfa and ribavirin genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in combination with ribavirin SOVALDI is used to treat children 3 years of age and older with chronic HCV genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. It is not known if SOVALDI is safe and effective in children under 3 years of age with HCV genotype 2 or 3 infection, or with HCV genotype 1 or 4 infection. It is not known if SOVALDI is safe and effective in people who have had a liver transplant. […]
From the patient leaflet: How should I store SOVALDI?Store SOVALDI tablets or pellets below 86°F (30°C). Keep SOVALDI tablets in the original container. Do not use SOVALDI tablets if the seal over the bottle opening is broken or missing. Do not use SOVALDI pellets if the carton tamper-evident seal, or the pellets packet seal, is broken or damaged. Keep SOVALDI and all medicines out of the reach of children.
Source: FDA drug label (Sovaldi), Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), via openFDA; the full label on DailyMed
Is there a generic for sofosbuvir (Sovaldi)?
The FDA approved the first generic sofosbuvir on January 27, 2022. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 9 patents for Sovaldi tablets: the compound patent runs to December 11, 2030 (pediatric exclusivity to June 11, 2031). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2022 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sofosbuvir label say about other medicines?
The sofosbuvir label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name sofosbuvir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | DRUG INTERACTIONS Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. ( 5.2 , 6.2 , 7.1 ) Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John's wort) may alter the concentrations of sofosbuvir. … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine phenytoin phenobarbital oxcarbazepine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; Clinical Comment: Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration … |
| Cyclosporine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Darunavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Efavirenz | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Emtricitabine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Methadone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine phenytoin phenobarbital oxcarbazepine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; Clinical Comment: Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine phenytoin phenobarbital oxcarbazepine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; Clinical Comment: Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: Carbamazepine phenytoin phenobarbital oxcarbazepine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; Clinical Comment: Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration … |
| Raltegravir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Ribavirin | contraindications | CONTRAINDICATIONS When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: Rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; Clinical Comment: Coadministration of SOVALDI with rifabutin or rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic … |
| Rifampin | drug interactions | DRUG INTERACTIONS Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. ( 5.2 , 6.2 , 7.1 ) Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John's wort) may alter the concentrations of sofosbuvir. … |
Every other medicine the sofosbuvir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: Rifabutin rifampin rifapentine; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; … |
| Rilpivirine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: HIV Protease Inhibitors: tipranavir/ritonavir; Effect on Concentration ↓ = decrease.: ↓ sofosbuvir ↓ GS-331007; … |
| Tacrolimus | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tenofovir disoproxil | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Warfarin | drug interactions | Frequent monitoring of relevant laboratory parameters (e.g. International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of … |
Other labels that name sofosbuvir
Source: FDA drug label (Sovaldi), Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), via openFDA; the full label on DailyMed
What do FAERS reports show for sofosbuvir?
The FDA Adverse Event Reporting System holds 19,615 reports that list sofosbuvir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,797 are coded as a death and 4,451 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (4,033, against a median of 198 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sofosbuvir?
3 other medicines are given the same way (oral) and in the same FDA class as sofosbuvir or labeled mainly for the same use (hepatitis c), the same class first. Hepatitis C lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ribavirin | Hepatitis C | 1 labeler | $0.451 per tablet 200 mg tablet | No current entry |
| Glecaprevir and pibrentasvir | Hepatitis C | none listed | $152.98 per tablet 100-40 mg tablet | No current entry |
| Elbasvir and grazoprevir | Hepatitis C | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as sofosbuvir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sofosbuvir
- 3 medicines for the same use
- Other hepatitis c virus nucleotide analog ns5b polymerase inhibitors
- the pharmacologic class, with prices and generics
- Sofosbuvir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other