Yonsa Generic: When Will Generic Abiraterone 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
Yonsa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2026 Sometime that year Why then?
- Has the FDA approved a generic? October 2018 12 companies approved
- When does the last patent end? May 2034 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 29 companies list one
It already is. A generic abiraterone acetate is listed for sale by 29 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2026?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Yonsa’s last patent runs to May 2034, how can a generic come sooner?
The 2 patents that run past the expected month, to May 2034 (9,889,144 and 10,292,990), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Yonsa’s patents with the FDA since July 2018. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Yonsa, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Yonsa by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $31M a yearSmaller seller
- FDA approved 2018 May 2018 FDA Orange Book
- Patents listed 2 last runs to May 2034 FDA Orange Book
- Generics FDA-approved 12 companies, the first approved October 2018 FDA Orange Book
- Medicare Part D spent $19.2M in 2025, for 271 people CMS Part D Spending by Drug
Yonsa’s Road to a Generic
Yonsa has had the market to itself since the FDA approved it in May 2018 (Sun Pharmaceutical Industries Ltd). Its 2 listed patents run to May 2034. Generic companies have challenged its patents with the FDA since July 2018.
The first generic of Yonsa is expected sometime in 2026.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before May 2034
The last listed patent runs to May 2034, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Yonsa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Yonsa’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,889,144 | The product’s formulation | March 2034 | Active |
| 10,292,990 | A way of using it (U-2535) | May 2034 | Active |
Source: FDA Orange Book, application 210308. Patent numbers open the patent on Google Patents.
Patent Challenges to Yonsa
The first patent challenge to Yonsa reached the FDA in July 2018, from one company on that first day. The FDA approved a first challenger’s generic in June 2022, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Yonsa’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 125 mg | July 2018 | 1 company | Decision deferred decided July 2022 | June 2022 | Not yet | March 2034 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Abiraterone Acetate
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
At least 12 companies have applied to the FDA to make generic abiraterone acetate.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Yonsa’s patents with the FDA since July 2018: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 12 companies, the first in October 2018. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic abiraterone acetate is listed for sale by 29 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., American Health Packaging, Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC, Apotex Corp., AvKARE and 23 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc | October 2018 | 250MG | AB |
| Hikma Pharmaceuticals LLC | October 2018 | 250MG | AB |
| Mylan Pharmaceuticals Inc | October 2018 | 250MG, 500MG | AB |
| Amneal Pharmaceuticals Of New York LLC | January 2019 | 250MG, 500MG | AB |
| Rising Pharma Holdings Inc | February 2019 | 250MG | AB |
| Wockhardt Bio AG | February 2019 | 250MG | AB |
| Msn Laboratories Private Ltd | July 2019 | 250MG, 500MG | AB |
| Qilu Pharmaceutical Co Ltd | September 2019 | 250MG, 500MG | AB |
| Glenmark Specialty SA | October 2019 | 250MG, 500MG | AB |
| Dr Reddys Laboratories Ltd | May 2020 | 250MG, 500MG | AB |
| Novugen Oncology Sdn Bhd | January 2022 | 250MG, 500MG | AB |
| Florida Pharmaceutical Products LLC | March 2023 | 500MG | AB |
| Teva Pharmaceuticals USA Inc discontinued | October 2018 | 125MG, 250MG, 500MG | – |
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).
Yonsa 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 Yonsa, 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 Yonsa
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 Yonsa, before manufacturer rebates.
- $3.9M
- January to March 2026, the latest CMS has posted
For 159 people, about $9,923 per prescription fill - $19.2M
- 2025, the whole year
For 271 people, about $10,143 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $3,909,599 | 159 | $9,922.84 |
| 2025 | $19,160,592 | 271 | $10,143.25 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Yonsa only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat men with prostate cancer. Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone).
Yonsa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 125MG | Tablet | Oral | May 2018 | Prescription reference product |
Source: FDA Orange Book, Sun Pharmaceutical Industries Ltd. Listed for sale today by Sun Pharmaceutical Industries, Inc. (FDA NDC Directory).
Yonsa NDC Codes and Packages
Each Yonsa 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 |
|---|---|---|---|
| 47335-0401-81 | ABIRATERONE ACETATE 125 mg/1 tablet | bottle of 120 tablets | Sun Pharmaceutical Industries, Inc. |
| 47335-0401-81 | ABIRATERONE ACETATE 125 mg/1 tablet | bottle of 120 tablets | Sun Pharmaceutical Industries, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Yonsa’s own FDA approval (NDA 210308) are listed, never a generic. Some codes belong to companies that repackage Yonsa: it is the same medicine in a different package.
What a Generic Yonsa Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Yonsa
Is there a generic for Yonsa right now?
Yes. The FDA NDC Directory lists a generic abiraterone acetate from 29 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Yonsa go generic?
It already has. The FDA NDC Directory lists a generic abiraterone acetate from 29 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic abiraterone acetate be the same as Yonsa?
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. At least 12 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Yonsa?
Yes. The FDA Orange Book lists approved generic versions from 12 companies, the first approved in October 2018: Apotex Inc, Hikma Pharmaceuticals LLC, Mylan Pharmaceuticals Inc, Amneal Pharmaceuticals Of New York LLC and 8 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Yonsa patent expire?
The FDA Orange Book lists 2 patents for Yonsa; the last runs to May 2034. 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 window on this page (Sometime in 2026) weighs all of that.
Has anyone challenged the Yonsa patents?
Yes. The first patent challenge to Yonsa reached the FDA in July 2018, from one company on that first day. The FDA approved a first challenger’s generic in June 2022, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected Sometime in 2026 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
- InvokanaCanagliflozin2027 to 2028
- NuvessaMetronidazole2030 to 2031
- Viekira PakDasabuvir Sodium, Ombitasvir, Paritaprevir, and RitonavirApril 2031
- SeglurometErtugliflozin and Metformin HydrochlorideDecember 2031
- DsuviaSufentanil CitrateFebruary 2038
- AlvaizEltrombopag CholineOctober 2038
About Yonsa
- Generic name abiraterone acetate
- How it is taken By mouth
- Company Sun Pharmaceutical Industries Ltd
- Patent challenges Since July 2018 (FDA)
- More drugs Brand-name drugs starting with Y
- Have a question? A pharmacist answers, free. Ask about Yonsa
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, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.