Nubeqa Generic: When Will Generic Darolutamide 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
Nubeqa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2033 About 6.5 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? June 2042 10 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 darolutamide is expected to be available in March 2033, about 6.5 years away. None is for sale yet.
Why March 2033?
It is when Nubeqa’s patent 8,975,254 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, 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 Nubeqa’s last patent runs to June 2042, how can a generic come sooner?
The 6 patents that run past the expected month, to June 2042 (10,010,530, 10,383,853, 10,835,515, 11,168,058 and 2 more), 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. Generic companies have been challenging Nubeqa’s patents with the FDA since July 2023. 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, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Nubeqa 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.
Nubeqa 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
- Moderate 3 companies have filed, 1 first in line
- Brand sales
- $3.1B a yearBlockbuster
- FDA approved 2019 July 2019 FDA Orange Book
- Patents listed 10 last runs to June 2042 A generic is expected sooner, in March 2033. See why FDA Orange Book
- Medicare Part D spent $2.2B in 2025, for 26K people CMS Part D Spending by Drug
- Medicaid prescriptions 8,934 in the last four reported quarters, $121.7M CMS Medicaid drug utilization, to Q1 2026
Nubeqa’s Road to a Generic
Nubeqa has had the market to itself since the FDA approved it in July 2019 (Bayer Healthcare Pharmaceuticals Inc). Its FDA protection (new use) runs to June 2028. Its 10 listed patents run to June 2042. Generic companies have challenged its patents with the FDA since July 2023.
The first generic of Nubeqa is expected in March 2033.
Why that month: patent 8,975,254, on the active ingredient, the product’s formulation and a way of using it, ends then. That is about 9 years before the last listed patent runs out, in June 2042.
Why a Generic Can Come Before June 2042
The last listed patent runs to June 2042; 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.
Nubeqa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Nubeqa’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: patent 8,975,254, which ends in March 2033, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,657,003 | The active ingredient; the product’s formulation; a way of using it (U-4209, U-4208, U-4210) | October 2030 | Active |
| 10,711,013 | The active ingredient; the product’s formulation | October 2030 | Active |
| 11,046,713 | The active ingredient | October 2030 | Active |
| 8,975,254 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-4208, U-4210, U-4209) | March 2033 | Active |
| 10,010,530 | The active ingredient | January 2036 | Active |
| 10,383,853 | The active ingredient | January 2036 | Active |
| 10,835,515 | The product’s formulation; a way of using it (U-4210, U-4208, U-4209, U-2605) | January 2036 | Active |
| 11,168,058 | The active ingredient; the product’s formulation | February 2038 | Active |
| 12,611,397 | The product’s formulation | July 2040 | Active |
| 12,329,742 | The product’s formulation | June 2042 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-971 | Three years of protection for a newly approved use (indication). | June 2028 | Active |
Source: FDA Orange Book, application 212099. Patent numbers open the patent on Google Patents.
Patent Challenges to Nubeqa
The first patent challenge to Nubeqa reached the FDA in July 2023, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Nubeqa’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, 300 mg | July 2023 | 1 company | No decision yet | Not yet | Not yet | February 2038 |
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 Darolutamide
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
3 companies have applied to the FDA to make generic darolutamide.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
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 Nubeqa’s patents with the FDA since July 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic darolutamide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic darolutamide 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).
Nubeqa 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 Nubeqa, 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 Nubeqa
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 Nubeqa, before manufacturer rebates.
- $808.6M
- January to March 2026, the latest CMS has posted
For 23,775 people, about $13,834 per prescription fill - $2.2B
- 2025, the whole year
For 26,013 people, about $13,227 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $808,648,248 | 23,775 | $13,834.16 |
| 2025 | $2,240,902,361 | 26,013 | $13,227.45 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Nubeqa only, so no generic is counted in it. What CMS says it is used for: Darolutamide is used to treat a certain type of prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone).
Medicaid Prescriptions by Quarter
8,934 prescriptions in the four quarters to Q1 2026, $121.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 2,377 | $33,922,260 |
| Q4 2025 | 2,471 | $33,123,747 |
| Q3 2025 | 2,197 | $29,349,304 |
| Q2 2025 | 1,889 | $25,298,968 |
| Q1 2025 | 1,660 | $22,057,709 |
Source: CMS Medicaid State Drug Utilization Data, over Nubeqa’s own package codes.
Nubeqa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 300MG | Tablet | Oral | July 2019 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer HealthCare Pharmaceuticals Inc. (FDA NDC Directory).
Nubeqa NDC Codes and Packages
Each Nubeqa 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 |
|---|---|---|---|
| 50419-0395-01 | DAROLUTAMIDE 300 mg/1 tablet, film coated | bottle of 120 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0395-01 | DAROLUTAMIDE 300 mg/1 tablet, film coated | bottle of 120 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0395-72 | DAROLUTAMIDE 300 mg/1 tablet, film coated | bottle of 120 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0395-72 | DAROLUTAMIDE 300 mg/1 tablet, film coated | bottle of 120 tablets | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Nubeqa’s own FDA approval (NDA 212099) are listed, never a generic. Some codes belong to companies that repackage Nubeqa: it is the same medicine in a different package.
What a Generic Nubeqa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Nubeqa 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 Nubeqa”. 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 Nubeqa
Is there a generic for Nubeqa right now?
No. As of October 9, 2026 no generic darolutamide is listed for sale in the FDA NDC Directory.
When will Nubeqa go generic?
March 2033 is the expected month, and that is probable but not certain. It is when Nubeqa’s patent 8,975,254 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2042; a court ruling or a settlement can bring a generic sooner.
Will generic darolutamide be the same as Nubeqa?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Nubeqa?
Not yet. The FDA Orange Book lists no approved generic version of Nubeqa.
When does the Nubeqa patent expire?
The FDA Orange Book lists 10 patents for Nubeqa; the last runs to June 2042. The one behind the expected month is patent 8,975,254, which ends in March 2033. 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 (March 2033) weighs all of that.
Has anyone challenged the Nubeqa patents?
Yes. The first patent challenge to Nubeqa reached the FDA in July 2023, from one company on that first day. The FDA has not approved a first challenger’s generic 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 March 2033 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
- BryhaliHalobetasol PropionateDuring 2026
- Tobi PodhalerTobramycinNovember 2030
- LivmarliMaralixibat ChlorideJanuary to June 2032
- YutrepiaTreprostinil SodiumMay 2037
- FocinvezFosaprepitant DimeglumineJanuary 2039
- PosimirBupivacaineJanuary 2041
About Nubeqa
- Generic name darolutamide
- How it is taken By mouth
- Company Bayer Healthcare Pharmaceuticals Inc
- Patent challenges Since July 2023 (FDA)
- More drugs Brand-name drugs starting with N
- Have a question? A pharmacist answers, free. Ask about Nubeqa
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.