Akeega Generic: When Will Generic Abiraterone and Niraparib Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Akeega Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2037 About 11 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? March 2038 13 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic abiraterone acetate and niraparib tosylate is expected to be available in July 2037, about 11 years away. None is for sale yet.
Why July 2037?
It is when Akeega’s patents 11,992,486 and 12,383,543 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Akeega’s last patent runs to March 2038, how can a generic come sooner?
The 2 patents that run past the expected month, to March 2038 (11,091,459 and 11,673,877), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Akeega as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Akeega by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $10M a yearSmaller seller
- FDA approved 2023 August 2023 FDA Orange Book
- Patents listed 13 last runs to March 2038 A generic is expected sooner, in July 2037. See why FDA Orange Book
- Medicare Part D spent $7.4M in 2025, for 93 people CMS Part D Spending by Drug
Akeega’s Road to a Generic
Akeega has had the market to itself since the FDA approved it in August 2023 (Janssen Biotech Inc). Its FDA protection (new use) runs to December 2028. Its 13 listed patents run to March 2038.
The first generic of Akeega is expected in July 2037.
Why that month: patents 11,992,486 and 12,383,543, on a way of using it, end then. That is a few months before the last listed patent runs out, in March 2038.
Why a Generic Can Come Before March 2038
The last listed patent runs to March 2038; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Akeega Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Akeega’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patents 11,992,486 and 12,383,543, which end in July 2037, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,071,579 | A way of using it (U-2830, U-4368) | August 2027 | Active |
| 8,143,241 | A way of using it (U-2830, U-4368) | August 2027 | Active |
| 8,436,185 | The active ingredient; the product’s formulation | April 2029 | Active |
| 8,071,623 | The active ingredient; the product’s formulation | March 2031 | Active |
| 8,859,562 | A way of using it (U-2830, U-4368) | August 2031 | Active |
| 11,207,311 | A way of using it (U-2830, U-4368) | July 2037 | Active |
| 11,986,468 | A way of using it (U-4368, U-2830) | July 2037 | Active |
| 11,986,469 | A way of using it (U-4368, U-2830) | July 2037 | Active |
| 11,986,470 | A way of using it (U-4368) | July 2037 | Active |
| 11,992,486 Sets the expected month of generic availability | A way of using it (U-4368, U-2830) | July 2037 | Active |
| 12,383,543 Sets the expected month of generic availability | A way of using it (U-4368, U-2830) | July 2037 | Active |
| 11,091,459 | The active ingredient; the product’s formulation | March 2038 | Active |
| 11,673,877 | The active ingredient; the product’s formulation; a way of using it (U-2830, U-4368) | March 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | August 2026 | Ended |
| New use I-980 | Three years of protection for a newly approved use (indication). | December 2028 | Active |
Source: FDA Orange Book, application 216793. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Abiraterone Acetate and Niraparib Tosylate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Akeega yet.
Approved by the FDA
Not yet. The FDA has not approved a generic abiraterone acetate and niraparib tosylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic abiraterone acetate and niraparib tosylate for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Akeega Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Akeega, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Akeega
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Akeega, before manufacturer rebates.
- $2.4M
- January to March 2026, the latest CMS has posted
For 68 people, about $18,008 per prescription fill - $7.4M
- 2025, the whole year
For 93 people, about $17,818 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,449,085 | 68 | $18,007.98 |
| 2025 | $7,358,817 | 93 | $17,817.96 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Akeega only, so no generic is counted in it. What CMS says it is used for: This combination medication is used to treat prostate cancer. It contains 2 medications: niraparib and abiraterone.
Akeega Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 500MG;EQ 100MG BASE | Tablet | Oral | August 2023 | Prescription reference product |
| 500MG;EQ 50MG BASE | Tablet | Oral | August 2023 | Prescription reference product |
Source: FDA Orange Book, Janssen Biotech Inc. Listed for sale today by Janssen Biotech, Inc. (FDA NDC Directory).
Akeega NDC Codes and Packages
Each Akeega package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 57894-0100-60 | NIRAPARIB TOSYLATE MONOHYDRATE 100 mg/1 / ABIRATERONE ACETATE 500 mg/1 tablet, film coated | bottle of 60 tablets | Janssen Biotech, Inc. |
| 57894-0100-60 | NIRAPARIB TOSYLATE MONOHYDRATE 100 mg/1 / ABIRATERONE ACETATE 500 mg/1 tablet, film coated | bottle of 60 tablets | Janssen Biotech, Inc. |
| 57894-0050-60 | NIRAPARIB TOSYLATE MONOHYDRATE 50 mg/1 / ABIRATERONE ACETATE 500 mg/1 tablet, film coated | bottle of 60 tablets | Janssen Biotech, Inc. |
| 57894-0050-60 | NIRAPARIB TOSYLATE MONOHYDRATE 50 mg/1 / ABIRATERONE ACETATE 500 mg/1 tablet, film coated | bottle of 60 tablets | Janssen Biotech, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Akeega’s own FDA approval (NDA 216793) are listed, never a generic. Some codes belong to companies that repackage Akeega: it is the same medicine in a different package.
What a Generic Akeega Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Akeega as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Akeega”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Akeega
Is there a generic for Akeega right now?
No. As of October 9, 2026 no generic abiraterone acetate and niraparib tosylate is listed for sale in the FDA NDC Directory.
When will Akeega go generic?
July 2037 is the expected month, and that is probable but not certain. It is when Akeega’s patents 11,992,486 and 12,383,543 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to March 2038; a court ruling or a settlement can bring a generic sooner.
Will generic abiraterone acetate and niraparib tosylate be the same as Akeega?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Akeega?
Not yet. The FDA Orange Book lists no approved generic version of Akeega.
When does the Akeega patent expire?
The FDA Orange Book lists 13 patents for Akeega; the last runs to March 2038. The one behind the expected month is patents 11,992,486 and 12,383,543, which end in July 2037. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (July 2037) weighs all of that.
Changes to This Projection
- First generic expected July 2037 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- BonjestaDoxylamine Succinate and Pyridoxine Hydrochloride2026 to 2027
- LinzessLinaclotideMarch 2029
- PiqrayAlpelisibApril 2033
- FirdapseAmifampridine PhosphateJanuary 2035
- XyostedTestosterone EnanthateSeptember 2036
- TembexaBrincidofovirTBD no date yet
About Akeega
- Generic name abiraterone acetate and niraparib tosylate
- How it is taken By mouth
- Company Janssen Biotech Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Akeega
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.