Prescription medicine
Elbasvir and grazoprevir Brand names: Zepatier
Elbasvir and grazoprevir (Zepatier) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the elbasvir and grazoprevir FDA label on DailyMed (effective March 13, 2026, Merck Sharp & Dohme LLC); the NDA 208261 record on Drugs@FDA; every elbasvir and grazoprevir label on DailyMed.
Highlights of the record
FDA label of March 13, 2026; 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 ZEPATIER. 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 usageZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg.
Forms and strengths
- 50 mg / 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 28, 2016 Zepatier, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 4, 2031 Zepatier tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,243 through July 30, 2026
What is elbasvir and grazoprevir used for?
From the label: indications and usageZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ]. ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations.
Conditions named in the indications of elbasvir and grazoprevir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis C Virus NS3/4A Protease Inhibitor and Hepatitis C Virus NS5A Inhibitor.
Source: FDA drug label (ZEPATIER), Merck Sharp & Dohme LLC, effective March 13, 2026 (SPL set 164dc02a-9180-426a-b8b5-04ab39d2bbd4), via openFDA; the full label on DailyMed
What does the patient leaflet for elbasvir and grazoprevir 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 ZEPATIER?ZEPATIER can cause serious side effects, including, Hepatitis B virus reactivation: Before starting treatment with ZEPATIER, 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 infection with ZEPATIER. 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 ZEPATIER. For more information about side effects, see the section " What are the possible side effects of ZEPATIER? " What is ZEPATIER ® ? ZEPATIER is a prescription medicine used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults and children 12 years of age and older or weighing at least 66 pounds (30 kilograms). ZEPATIER should not be used in children younger than 12 years of age who weigh less than 66 pounds (30 kilograms). It is not known if ZEPATIER is safe or effective in people awaiting a liver transplant or people who have had a liver transplant. Who should not take ZEPATIER? Do not take ZEPATIER if you have certain liver problems.
Source: FDA drug label (ZEPATIER), Merck Sharp & Dohme LLC, effective March 13, 2026 (SPL set 164dc02a-9180-426a-b8b5-04ab39d2bbd4), via openFDA; the full label on DailyMed
Is there a generic for elbasvir and grazoprevir (Zepatier)?
No generic elbasvir and grazoprevir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Zepatier tablets: the compound patent runs to May 4, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is elbasvir and grazoprevir in shortage?
No elbasvir and grazoprevir presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated October 17, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Zepatier, Tablet, 50 mg; 100 mg (NDC 0006-3074-02) | Merck Sharp & Dohme LLC | To Be Discontinued | October 17, 2025 |
Every elbasvir and grazoprevir presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the elbasvir and grazoprevir label say about other medicines?
The elbasvir and grazoprevir label names 37 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name elbasvir and grazoprevir. 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 |
|---|---|---|
| Abacavir | drug interactions | No clinically relevant drug-drug interaction is expected when ZEPATIER is co-administered with abacavir, emtricitabine, entecavir, and lamivudine. |
| Atazanavir | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: Atorvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ atorvastatin; Clinical Comment: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER. |
| Bosentan | drug interactions | Concomitant Drug Class/Drug Name: Endothelin Antagonists: Bosentan; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ EBR ↓ GZR; Clinical Comment: Co-administration of ZEPATIER with bosentan may lead to reduced therapeutic effect of ZEPATIER. Co-administration is not recommended. |
| Buprenorphine and naloxone | drug interactions | Drugs without Clinically Significant Interactions with ZEPATIER The interaction between the components of ZEPATIER (elbasvir or grazoprevir) or ZEPATIER and the following drugs were evaluated in clinical studies, and no dose adjustments are needed when ZEPATIER is used with the following drugs individually: acid … |
| Carbamazepine | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Cobicistat | drug interactions | Concomitant Drug Class/Drug Name: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir (disoproxil fumarate or alafenamide); Effect on Concentration ↓ = decrease, ↑ = increase: ↑ EBR ↑ GZR; Clinical Comment: Co-administration of cobicistat-containing regimens is not recommended. |
| Cyclosporine | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Darunavir | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Digoxin | drug interactions | … individually: acid reducing agents (proton pump inhibitors, H2 blockers, antacids), buprenorphine/naloxone, digoxin, dolutegravir, methadone, mycophenolate mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate … |
| Dolutegravir | drug interactions | … individually: acid reducing agents (proton pump inhibitors, H2 blockers, antacids), buprenorphine/naloxone, digoxin, dolutegravir, methadone, mycophenolate mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate … |
| Efavirenz | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Emtricitabine | drug interactions | Concomitant Drug Class/Drug Name: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir (disoproxil fumarate or alafenamide); Effect on Concentration ↓ = decrease, ↑ = increase: ↑ EBR ↑ GZR; Clinical Comment: Co-administration of cobicistat-containing regimens is not recommended. |
| Entecavir | drug interactions | No clinically relevant drug-drug interaction is expected when ZEPATIER is co-administered with abacavir, emtricitabine, entecavir, and lamivudine. |
Every other medicine the elbasvir and grazoprevir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name: Etravirine; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ EBR ↓ GZR; Clinical Comment: Co-administration of ZEPATIER with etravirine may lead to reduced … |
| Fluvastatin | drug interactions | Concomitant Drug Class/Drug Name: Fluvastatin Lovastatin Simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ fluvastatin ↑ lovastatin ↑ simvastatin; … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: oral Ketoconazole These interactions have been studied in healthy adults.; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ EBR ↑ GZR; … |
| Lamivudine | drug interactions | No clinically relevant drug-drug interaction is expected when ZEPATIER is co-administered with abacavir, emtricitabine, entecavir, and lamivudine. |
| Lovastatin | drug interactions | Concomitant Drug Class/Drug Name: Fluvastatin Lovastatin Simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ fluvastatin ↑ lovastatin ↑ simvastatin; … |
| Methadone | drug interactions | … blockers, antacids), buprenorphine/naloxone, digoxin, dolutegravir, methadone, mycophenolate mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir … |
| Modafinil | drug interactions | Concomitant Drug Class/Drug Name: Wakefulness-Promoting Agents: Modafinil; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ EBR ↓ GZR; … |
| Mycophenolate mofetil | drug interactions | … antacids), buprenorphine/naloxone, digoxin, dolutegravir, methadone, mycophenolate mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin … |
| Nafcillin | drug interactions | Concomitant Drug Class/Drug Name: Antibiotics: Nafcillin; Effect on Concentration ↓ = decrease, ↑ = increase: ↓ EBR ↓ GZR; … |
| Phenytoin | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Pitavastatin | drug interactions | … mycophenolate mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see … |
| Pravastatin | drug interactions | … mofetil, oral contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical … |
| Prednisone | drug interactions | … contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical Pharmacology (12.3) ]. |
| Raltegravir | drug interactions | … contraceptive pills, phosphate binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical Pharmacology (12.3) ]. |
| Ribavirin | contraindications | If ZEPATIER is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. |
| Rifampin | contraindications | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Rilpivirine | drug interactions | … binders, pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical Pharmacology (12.3) ]. |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: Rosuvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ rosuvastatin; Clinical Comment: The dose of rosuvastatin should not exceed a daily dose of 10 mg … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: Fluvastatin Lovastatin Simvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ fluvastatin ↑ lovastatin ↑ simvastatin; … |
| Sofosbuvir | drug interactions | … raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical Pharmacology (12.3) ]. |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Tacrolimus; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tacrolimus; … |
| Tenofovir disoproxil | drug interactions | … pitavastatin, pravastatin, prednisone, raltegravir, ribavirin, rilpivirine, tenofovir disoproxil fumarate, and sofosbuvir [see Clinical Pharmacology (12.3) ]. |
| 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 elbasvir and grazoprevir
Source: FDA drug label (ZEPATIER), Merck Sharp & Dohme LLC, effective March 13, 2026 (SPL set 164dc02a-9180-426a-b8b5-04ab39d2bbd4), via openFDA; the full label on DailyMed
What do FAERS reports show for elbasvir and grazoprevir?
The FDA Adverse Event Reporting System holds 4,243 reports that list elbasvir and grazoprevir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 574 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 2017 (2,382, against a median of 69 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 elbasvir and grazoprevir?
6 other medicines are given the same way (oral) and in the same FDA class as elbasvir and grazoprevir 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 |
|---|---|---|---|---|
| Ledipasvir and sofosbuvir | Hepatitis C | none listed | n/a | No current entry |
| Sofosbuvir and velpatasvir | Hepatitis C | none listed | $278.03 per unit 400-100 | No current entry |
| Glecaprevir and pibrentasvir | Hepatitis C | none listed | $152.98 per tablet 100-40 mg tablet | No current entry |
| Sofosbuvir and velpatasvir and voxilaprevir | Hepatitis C | none listed | n/a | No current entry |
| Ribavirin | Hepatitis C | 1 labeler | $0.451 per tablet 200 mg tablet | No current entry |
| Sofosbuvir | Hepatitis C | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as elbasvir and grazoprevir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to elbasvir and grazoprevir
- 6 medicines for the same use
- Other hepatitis c virus ns3/4a protease inhibitors
- the pharmacologic class, with prices and generics
- Elbasvir and grazoprevir side effects
- the label's list beside FAERS reports
- Elbasvir and grazoprevir shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other