Prescription medicine
Enzalutamide Brand names: Xtandi
Enzalutamide (Xtandi) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the enzalutamide FDA label on DailyMed (effective July 28, 2026, Astellas Pharma US, Inc.); the NDA 203415 record on Drugs@FDA; every enzalutamide label on DailyMed.
Highlights of the record
FDA label of July 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXTANDI ® is indicated for the treatment of patients with:
castration-resistant prostate cancer (CRPC)
metastatic castration-sensitive prostate cancer (mCSPC)
non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:
castration-resistant prostate canc
Forms and strengths
- 40 mg
- 80 mg
Tablet; capsule.
On the market
- Earliest approval on file
- August 31, 2012 Xtandi, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first May 14, 2021; 1 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
- February 23, 2037 Xtandi 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
- 58,437 through July 30, 2026
What is enzalutamide used for?
From the label: indications and usageXTANDI ® is indicated for the treatment of patients with:
castration-resistant prostate cancer (CRPC)
metastatic castration-sensitive prostate cancer (mCSPC)
non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:
castration-resistant prostate cancer. ( 1 )
metastatic castration-sensitive prostate cancer. ( 1 )
non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Conditions named in the indications of enzalutamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Androgen Receptor Inhibitor.
Source: FDA drug label (Xtandi), Astellas Pharma US, Inc., effective July 28, 2026 (SPL set b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf), via openFDA; the full label on DailyMed
Is there a generic for enzalutamide (Xtandi)?
The FDA approved the first generic enzalutamide on May 14, 2021. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 7 patents for Xtandi tablets: the compound patent runs to August 13, 2027, and the last listed entry to February 23, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2021 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the enzalutamide label say about other medicines?
The enzalutamide label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name enzalutamide. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. |
| Clopidogrel | drug interactions | … quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as enzalutamide may decrease their exposure. |
| Cyclosporine | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Digoxin | drug interactions | Laboratory Test Interference XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. |
| Dihydroergotamine | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Ergotamine | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Fentanyl | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Gemfibrozil | drug interactions | Drugs on XTANDI Strong CYP2C8 Inhibitors The coadministration of XTANDI with gemfibrozil (a strong CYP2C8 inhibitor) increases plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may increase the incidence and severity of adverse reactions of XTANDI. |
| Midazolam | drug interactions | At steady-state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). |
| Omeprazole | drug interactions | At steady-state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). |
| Phenobarbital | drug interactions | Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. |
| Phenytoin | drug interactions | Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. |
| Pimozide | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Quinidine | drug interactions | Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
Every other medicine the enzalutamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifabutin | drug interactions | Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. |
| Rifampin | drug interactions | Strong CYP3A4 Inducers The coadministration of XTANDI with rifampin (a strong CYP3A4 inducer and a moderate CYP2C8 inducer) decreases plasma concentrations of enzalutamide plus N-desmethyl … |
| Rifapentine | drug interactions | Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. |
| Sirolimus | drug interactions | … cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be … |
| Tacrolimus | drug interactions | … dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as … |
| Warfarin | drug interactions | If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. |
Other labels that name enzalutamide
Source: FDA drug label (Xtandi), Astellas Pharma US, Inc., effective July 28, 2026 (SPL set b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf), via openFDA; the full label on DailyMed
What do FAERS reports show for enzalutamide?
The FDA Adverse Event Reporting System holds 58,437 reports that list enzalutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,360 are coded as a death and 11,077 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 (10,285, against a median of 2,631 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 enzalutamide?
6 other medicines are given the same way (oral) and in the same FDA class as enzalutamide or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 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 |
|---|---|---|---|---|
| Nilutamide | Prostate cancer | 1 labeler | n/a | A presentation being discontinued |
| Abiraterone | Prostate cancer | 24 labelers | $0.774 per tablet 250 mg tablet | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone and niraparib | Prostate cancer | none listed | n/a | No current entry |
| Apalutamide | Prostate cancer | none listed | n/a | No current entry |
| Relugolix | Prostate cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as enzalutamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does enzalutamide compare with medicines for the same use?
1 side-by-side page set enzalutamide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to enzalutamide
- 6 medicines for the same use
- Other androgen receptor inhibitors
- the pharmacologic class, with prices and generics
- Enzalutamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other