Prescription medicine
Abiraterone and niraparib Brand names: Akeega
Abiraterone and niraparib (Akeega) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the abiraterone and niraparib FDA label on DailyMed (effective December 18, 2025, Janssen Biotech, Inc.); the NDA 216793 record on Drugs@FDA; every abiraterone and niraparib label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC).
Forms and strengths
- 50 mg / 500 mg
- 100 mg / 500 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 11, 2023 Akeega, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 27, 2038 Akeega 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
- 51 through July 30, 2026
What is abiraterone and niraparib used for?
From the label: indications and usageAKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ]. […]
Conditions named in the indications of abiraterone and niraparib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cytochrome P450 17A1 Inhibitor and Poly(ADP-Ribose) Polymerase Inhibitor.
Source: FDA drug label (AKEEGA), Janssen Biotech, Inc., effective December 18, 2025 (SPL set 8245a990-3268-4613-b5c5-9537858a1eb9), via openFDA; the full label on DailyMed
What does the patient leaflet for abiraterone and niraparib 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 AKEEGA?AKEEGA may cause serious side effects including: Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). MDS or AML that may lead to death has happened in people treated with AKEEGA. If you develop MDS or AML, your healthcare provider will stop treatment with AKEEGA. Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with AKEEGA but can also be a sign of serious bone marrow problems, including MDS and AML. Tell your healthcare provider if you have any of the following symptoms during treatment with AKEEGA: pale skin weakness shortness of breath feeling tired bruising or bleeding more easily fever frequent infections blood in urine or stool weight loss Your healthcare provider will do blood tests to check your blood cell counts: weekly during the first month of treatment, every 2 weeks for the next 2 months of treatment, monthly for the remainder of the year, then every other month and as needed during treatment with AKEEGA. See " What are the possible side effects of AKEEGA? " for more information about side effects.
From the patient leaflet: How should I store AKEEGA?Store AKEEGA at room temperature between 68°F to 77°F (20°C to 25°C). Keep AKEEGA and all medicines out of the reach of children.
Source: FDA drug label (AKEEGA), Janssen Biotech, Inc., effective December 18, 2025 (SPL set 8245a990-3268-4613-b5c5-9537858a1eb9), via openFDA; the full label on DailyMed
Is there a generic for abiraterone and niraparib (Akeega)?
No generic abiraterone and niraparib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Akeega tablets: the compound patent runs to March 27, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the abiraterone and niraparib label say about other medicines?
The abiraterone and niraparib label names 4 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 |
|---|---|---|
| Pioglitazone | warnings and precautions | Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide. |
| Prednisone | warnings and precautions | Use of AKEEGA plus prednisone in combination with radium Ra 223 dichloride is not recommended. ( 5.7 ) Posterior Reversible Encephalopathy Syndrome (PRES): |
| Radium ra 223 dichloride | warnings and precautions | Monitor blood glucose in patients with diabetes during and assess if antidiabetic agent dose modifications are required. ( 5.6 ) Increased fractures and mortality in combination with radium Ra 223 dichloride: |
| Repaglinide | warnings and precautions | Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide. |
Source: FDA drug label (AKEEGA), Janssen Biotech, Inc., effective December 18, 2025 (SPL set 8245a990-3268-4613-b5c5-9537858a1eb9), via openFDA; the full label on DailyMed
What do FAERS reports show for abiraterone and niraparib?
The FDA Adverse Event Reporting System holds 51 reports that list abiraterone and niraparib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 16 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 else is labeled for the same conditions as abiraterone and niraparib?
7 other medicines are given the same way (oral) and in the same FDA class as abiraterone and niraparib 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 |
|---|---|---|---|---|
| Talazoparib | Prostate cancer | none listed | n/a | No current entry |
| Olaparib | Prostate cancer | none listed | n/a | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Enzalutamide | 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 and niraparib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to abiraterone and niraparib
- 7 medicines for the same use
- Other cytochrome p450 17a1 inhibitors
- the pharmacologic class, with prices and generics
- Abiraterone and niraparib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other