Prescription medicine
Apalutamide Brand names: Erleada
Apalutamide (Erleada) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the apalutamide FDA label on DailyMed (effective July 2, 2026, Janssen Products, LP); the NDA 210951 record on Drugs@FDA; every apalutamide label on DailyMed.
Highlights of the record
FDA label of July 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
Forms and strengths
- 60 mg
- 240 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 14, 2018 Erleada, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 17, 2025; 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
- January 14, 2041 Erleada 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
- 11,688 through July 30, 2026
What is apalutamide used for?
From the label: indications and usageERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer.
Conditions named in the indications of apalutamide's FDA labels, with every medicine labeled for each:
Source: FDA drug label (ERLEADA), Janssen Products, LP, effective July 2, 2026 (SPL set d1cda4f7-cb33-46ea-b9ac-431f6452b1a5), via openFDA; the full label on DailyMed
Is there a generic for apalutamide (Erleada)?
The FDA approved the first generic apalutamide on March 17, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 14 patents for Erleada tablets: the compound patent runs to June 4, 2033, and the last listed entry to January 14, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2025 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the apalutamide label say about other medicines?
The apalutamide label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 6 other medicines name apalutamide. 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 |
|---|---|---|
| Digoxin | drug interactions | Laboratory Test Interference ERLEADA can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. |
Other labels that name apalutamide
Source: FDA drug label (ERLEADA), Janssen Products, LP, effective July 2, 2026 (SPL set d1cda4f7-cb33-46ea-b9ac-431f6452b1a5), via openFDA; the full label on DailyMed
What do FAERS reports show for apalutamide?
The FDA Adverse Event Reporting System holds 11,688 reports that list apalutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,506 are coded as a death and 2,607 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 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 apalutamide?
6 other medicines are given the same way (oral) and in the same FDA class as apalutamide 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 |
|---|---|---|---|---|
| Abiraterone | Prostate cancer | 24 labelers | $0.774 per tablet 250 mg tablet | No current entry |
| Enzalutamide | Prostate cancer | none listed | n/a | 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 |
| Nilutamide | Prostate cancer | 1 labeler | n/a | A presentation being discontinued |
| Relugolix | Prostate cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as apalutamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to apalutamide
- 6 medicines for the same use
- Apalutamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other