Prescription medicine
Ensitrelvir Brand names: Xocova
Ensitrelvir (Xocova) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ensitrelvir FDA label on DailyMed (effective June 3, 2026, Shionogi Inc.); the NDA 220442 record on Drugs@FDA; every ensitrelvir label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.
Forms and strengths
- 125 mg
Tablet.
On the market
- Earliest approval on file
- May 29, 2026 Xocova, Shionogi; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 1, 2042 Xocova 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
- 18 through July 30, 2026
What is ensitrelvir used for?
From the label: indications and usageXOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro: also referred to as 3CL pro or nsp5 protease) inhibitor, is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.
Conditions named in the indications of ensitrelvir's FDA labels, with every medicine labeled for each:
Source: FDA drug label (XOCOVA), Shionogi Inc., effective June 3, 2026 (SPL set 526acf60-abc3-2cc2-e063-6294a90affa6), via openFDA; the full label on DailyMed
Is there a generic for ensitrelvir (Xocova)?
No generic ensitrelvir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Xocova tablets: the compound patent runs to May 1, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ensitrelvir label say about other medicines?
The ensitrelvir label names 20 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Apalutamide | drug interactions | Drug Class: Anticancer drugs; Drug (s) within Class: apalutamide, enzalutamide; Effect on Drug Concentration: ↓ ensitrelvir; Clinical Comment: Co-administration is contraindicated due to potential loss of virologic response. |
| Carbamazepine | drug interactions | Drug Class: Anticonvulsants; Drug (s) within Class: carbamazepine See, phenytoin; Effect on Drug Concentration: ↓ ensitrelvir; Clinical Comment: Co-administration is contraindicated due to potential loss of virologic response. |
| Colchicine | drug interactions | Drug Class: Antigout agents; Drug (s) within Class: colchicine; Effect on Drug Concentration: ↑ colchicine; Clinical Comment: Co-administration is contraindicated due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment. |
| Dihydroergotamine | drug interactions | Drug Class: Ergot derivatives; Drug (s) within Class: dihydroergotamine, ergotamine, methylergonovine; Effect on Drug Concentration: ↑ dihydroergotamine, ergotamine, methylergonovine; Clinical Comment: Co-administration is contraindicated due to potential for acute ergot toxicity characterized by vasospasm and … |
| Enzalutamide | drug interactions | Drug Class: Anticancer drugs; Drug (s) within Class: apalutamide, enzalutamide; Effect on Drug Concentration: ↓ ensitrelvir; Clinical Comment: Co-administration is contraindicated due to potential loss of virologic response. |
| Eplerenone | drug interactions | Drug Class: Cardiovascular drugs; Drug (s) within Class: eplerenone, ivabradine; Effect on Drug Concentration: ↑ eplerenone, ivabradine; Clinical Comment: Co-administration is contraindicated. |
| Ergotamine | drug interactions | Drug Class: Ergot derivatives; Drug (s) within Class: dihydroergotamine, ergotamine, methylergonovine; Effect on Drug Concentration: ↑ dihydroergotamine, ergotamine, methylergonovine; Clinical Comment: Co-administration is contraindicated due to potential for acute ergot toxicity characterized by vasospasm and … |
| Finerenone | drug interactions | Drug Class: Mineralocorticoid receptor antagonists; Drug (s) within Class: finerenone; Effect on Drug Concentration: ↑ finerenone; Clinical Comment: Co-administration is contraindicated due to potential for serious adverse reactions, including hyperkalemia, hypotension, and hyponatremia. |
| Ivabradine | drug interactions | Drug Class: Cardiovascular drugs; Drug (s) within Class: eplerenone, ivabradine; Effect on Drug Concentration: ↑ eplerenone, ivabradine; Clinical Comment: Co-administration is contraindicated. |
| Ivacaftor and lumacaftor | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Lomitapide | drug interactions | Drug Class: Microsomal triglyceride transfer protein (MTTP) inhibitors; Drug (s) within Class: lomitapide; Effect on Drug Concentration: ↑ lomitapide; Clinical Comment: Co-administration is contraindicated due to potential for hepatotoxicity and gastrointestinal adverse reactions. |
| Lurasidone | drug interactions | Drug Class: Antipsychotics; Drug (s) within Class: lurasidone, pimozide; Effect on Drug Concentration: ↑ lurasidone, pimozide; Clinical Comment: Co-administration is contraindicated due to serious and/or life-threatening reactions, such as cardiac arrhythmias. |
| Methylergonovine | drug interactions | Drug Class: Ergot derivatives; Drug (s) within Class: dihydroergotamine, ergotamine, methylergonovine; Effect on Drug Concentration: ↑ dihydroergotamine, ergotamine, methylergonovine; Clinical Comment: Co-administration is contraindicated due to potential for acute ergot toxicity characterized by vasospasm and … |
| Phenytoin | drug interactions | Drug Class: Anticonvulsants; Drug (s) within Class: carbamazepine See, phenytoin; Effect on Drug Concentration: ↓ ensitrelvir; Clinical Comment: Co-administration is contraindicated due to potential loss of virologic response. |
Every other medicine the ensitrelvir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pimozide | drug interactions | Drug Class: Antipsychotics; Drug (s) within Class: lurasidone, pimozide; Effect on Drug Concentration: ↑ lurasidone, pimozide; … |
| Quinidine | drug interactions | Drug Class: Antiarrhythmics; Drug (s) within Class: quinidine; Effect on Drug Concentration: ↑ antiarrhythmic; Clinical Comment: Co-administration is contraindicated due to potential for cardiac … |
| Rifampin | drug interactions | Drug Class: Antimycobacterials; Drug (s) within Class: rifampin; Effect on Drug Concentration: ↓ ensitrelvir; Clinical Comment: Co-administration is contraindicated due to potential loss of virologic … |
| Simvastatin | drug interactions | Drug Class: HMG-CoA reductase inhibitors (statins); Drug (s) within Class: simvastatin; Effect on Drug Concentration: ↑ simvastatin; Clinical Comment: Co-administration is contraindicated. … |
| Triazolam | drug interactions | Drug Class: Sedatives; Drug (s) within Class: triazolam; Effect on Drug Concentration: ↑ triazolam; Clinical Comment: Co-administration is contraindicated. |
| Voclosporin | drug interactions | Drug Class: Immunosuppressants; Drug (s) within Class: voclosporin; Effect on Drug Concentration: ↑ voclosporin; Clinical Comment: Co-administration is contraindicated due to potential for acute … |
Source: FDA drug label (XOCOVA), Shionogi Inc., effective June 3, 2026 (SPL set 526acf60-abc3-2cc2-e063-6294a90affa6), via openFDA; the full label on DailyMed
What do FAERS reports show for ensitrelvir?
The FDA Adverse Event Reporting System holds 18 reports that list ensitrelvir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ensitrelvir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other