Prescription medicine
Abiraterone Brand names: Zytiga, Yonsa, Abirtega
Abiraterone (Zytiga) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.774 per abiraterone acetate 250 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the abiraterone FDA label on DailyMed (effective March 28, 2025, Janssen Biotech, Inc.); the NDA 202379 record on Drugs@FDA; every abiraterone label on DailyMed.
Highlights of the record
FDA label of March 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Forms and strengths
- 125 mg
- 250 mg
- 500 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- April 28, 2011 Zytiga, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first October 31, 2018; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 23 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 20, 2034 Yonsa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.774 per tablet Abiraterone acetate 250 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 40,909 through July 30, 2026
What is abiraterone used for?
From the label: indications and usageZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC).
Conditions named in the indications of abiraterone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cytochrome P450 17A1 Inhibitor.
Source: FDA drug label (Zytiga), Janssen Biotech, Inc., effective March 28, 2025 (SPL set 4e338e89-3cf2-48eb-b6e2-a06c608c6513), via openFDA; the full label on DailyMed
Is there a generic for abiraterone (Zytiga)?
The FDA approved the first generic abiraterone on October 31, 2018. 15 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists abiraterone from 23 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zytiga tablets; a patent listed only for Yonsa tablets runs to May 20, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2018 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for abiraterone (Zytiga)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.774 per Abiraterone acetate 250 mg tablet, down 27% from $1.06 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Abiraterone acetate 250 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Abiraterone acetate 250 mg tablet | Generic | $0.774 per tablet | $23.22 | -27% |
| Abiraterone acetate 500 mg tablet | Generic | $2.59 per tablet | $77.83 | -71% |
| Abirtega 250 mg tablet | Generic | $0.774 per tablet | $23.22 | -27% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the abiraterone label say about other medicines?
The abiraterone label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name abiraterone. 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 |
|---|---|---|
| Dextromethorphan | drug interactions | In a CYP2D6 drug-drug interaction trial, the C max and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. |
| Ketoconazole | drug interactions | In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone [see Clinical Pharmacology (12.3) ]. |
| Methylprednisolone | warnings and precautions | Use of YONSA plus methylprednisolone in combination with radium Ra 223 dichloride is not recommended. |
| Pioglitazone | drug interactions | In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate. |
| Prednisolone | warnings and precautions | Use of ZYTIGA plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. |
| Prednisone | drug interactions | In a CYP2D6 drug-drug interaction trial, the C max and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. |
| Radium ra 223 dichloride | warnings and precautions | Monitor liver function and modify, interrupt, or discontinue ZYTIGA dosing as recommended. ( 5.3 ) Increased fractures and mortality in combination with radium Ra 223 dichloride: |
| Repaglinide | warnings and precautions | Severe hypoglycemia has been reported in patients with pre-existing diabetes who are taking medications containing thiazolidinediones (including pioglitazone) or repaglinide. |
| Rifampin | drug interactions | In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. |
| Thioridazine | drug interactions | Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). |
Other labels that name abiraterone
Source: FDA drug label (Zytiga), Janssen Biotech, Inc., effective March 28, 2025 (SPL set 4e338e89-3cf2-48eb-b6e2-a06c608c6513), via openFDA; the full label on DailyMed
What do FAERS reports show for abiraterone?
The FDA Adverse Event Reporting System holds 40,909 reports that list abiraterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8,375 are coded as a death and 11,020 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 abiraterone?
5 other medicines are given the same way (oral) and in the same FDA class as abiraterone 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 |
|---|---|---|---|---|
| Enzalutamide | Prostate cancer | none listed | n/a | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Apalutamide | 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 abiraterone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does abiraterone compare with medicines for the same use?
2 side-by-side pages set abiraterone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to abiraterone
- 5 medicines for the same use
- Other cytochrome p450 17a1 inhibitors
- the pharmacologic class, with prices and generics
- Abiraterone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other