Xtandi Generic: When Will Generic Enzalutamide 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
Xtandi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July to September 2027 A 3-month window Why then?
- Has the FDA approved a generic? May 2021 1 company approved Why not on sale?
- When does the last patent end? February 2037 7 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 enzalutamide is expected to be available between July and September 2027, first for Xtandi capsule. None is for sale yet. Each product has its own month below.
Why July to September 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Xtandi’s last patent runs to February 2037, how can a generic come sooner?
The 4 patents that run past the expected month, to February 2037 (11,839,689, 12,447,128, 12,502,357 and 12,161,628), 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 Xtandi’s patents with the FDA since August 2016. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since May 2021, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 8 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. See the price pattern
What should I do now?
Keep taking Xtandi 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
- capsuleJuly to September 2027Likely · settlement between companies
- tabletSometime in 2028Probable · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Xtandi 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
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Very strong 8 companies have filed, 4 first in line
- Brand sales
- $4.8B a yearBlockbuster, all 2 products
- FDA approved 2012 August 2012 FDA Orange Book
- Patents listed 7 last runs to February 2037 A generic is expected sooner, between July and September 2027. See why FDA Orange Book
- Generics FDA-approved 1 company, approved May 2021 FDA Orange Book
- Medicare Part D spent $5.1B in 2025, for 48.5K people CMS Part D Spending by Drug
- Medicaid prescriptions 9,508 in the last four reported quarters, $133.3M CMS Medicaid drug utilization, to Q1 2026
Xtandi’s Road to a Generic
Xtandi has had the market to itself since the FDA approved it in August 2012 (Astellas Pharma US Inc). Its FDA protection (new use) runs to November 2026. Its 7 listed patents run to February 2037 (2 already expired). Generic companies have challenged its patents with the FDA since August 2016.
The first generic of Xtandi is expected between July and September 2027.
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 February 2037
The last listed patent runs to February 2037, 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.
Xtandi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xtandi’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 |
|---|---|---|---|
| 9,126,941 | A way of using it (U-2345, U-1588, U-2708, U-3763) | May 2026 | Expired |
| 8,183,274 | A way of using it (U-1281, U-1588, U-2708, U-2345, U-3763) | August 2026 | Expired |
| 7,709,517 | The active ingredient; the product’s formulation | August 2027 | Active |
| 11,839,689 | The product’s formulation | September 2033 | Active |
| 12,447,128 | A way of using it (U-4312, U-4313, U-4314) | September 2033 | Active |
| 12,502,357 | A way of using it (U-4363, U-4364, U-4365) | September 2033 | Active |
| 12,161,628 | A way of using it (U-4101, U-4102, U-4103, U-4104) | February 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-926 | Three years of protection for a newly approved use (indication). | November 2026 | Active |
Source: FDA Orange Book, application 203415, 213674. Patent numbers open the patent on Google Patents.
Patent Challenges to Xtandi
The first patent challenge to Xtandi reached the FDA in August 2016, from 3 companies on that first day. The FDA’s list has 3 entries for Xtandi, by form and strength. The FDA approved a first challenger’s generic in May 2021, 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 Xtandi’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 | |||||
| Capsules, 40 mg | August 2016 | 3 companies | Head start still held decided September 2023 Earlier: decision deferred, June 2021 | May 2021 | Not yet | August 2027 |
| Tablets, 40 mg and 80 mg | March 2021 | 1 company | First challenger eligible decided April 2026 | April 2026 | Not yet | August 2027 |
| Tablets, 120 mg and 160 mg | December 2024 | 1 company | No decision yet | Not yet | Not yet | September 2033 |
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 Enzalutamide
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
8 companies have applied to the FDA to make generic enzalutamide.
The FDA has tentatively approved 3 companies’ generics: Zydus Pharms USA Inc (September 2024), Haimen Pharma Inc (June 2025) and Hikma Pharmaceuticals USA Inc (February 2026). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 4 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Xtandi’s patents with the FDA since August 2016: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in May 2021. 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
Not yet. No company lists a generic enzalutamide for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Sandoz Inc | April 2026 | 40MG, 80MG | AB |
| Actavis Laboratories Fl Inc discontinued | May 2021 | 40MG | – |
| Apotex Inc discontinued | April 2022 | 40MG | – |
| Zydus Pharmaceuticals USA Inc discontinued | September 2024 | 40MG | – |
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).
Xtandi 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 Xtandi, 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 Xtandi
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 Xtandi, before manufacturer rebates.
- $1.2B
- January to March 2026, the latest CMS has posted
For 35,813 people, about $13,813 per prescription fill - $5.1B
- 2025, the whole year
For 48,505 people, about $13,687 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,244,372,909 | 35,813 | $13,812.71 |
| 2025 | $5,134,377,355 | 48,505 | $13,687.18 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xtandi only, so no generic is counted in it. What CMS says it is used for: Enzalutamide is used to treat prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone).
Medicaid Prescriptions by Quarter
9,508 prescriptions in the four quarters to Q1 2026, $133.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 2,279 | $32,298,982 |
| Q4 2025 | 2,350 | $32,906,031 |
| Q3 2025 | 2,498 | $34,911,081 |
| Q2 2025 | 2,381 | $33,208,952 |
| Q1 2025 | 2,535 | $35,489,656 |
Source: CMS Medicaid State Drug Utilization Data, over Xtandi’s own package codes.
Xtandi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 40MG | Capsule | Oral | August 2012 | Prescription reference product |
| 40MG | Tablet | Oral | August 2020 | Prescription reference product |
| 80MG | Tablet | Oral | August 2020 | Prescription reference product |
Source: FDA Orange Book, Astellas Pharma US Inc. Listed for sale today by Astellas Pharma US, Inc. (FDA NDC Directory).
Xtandi NDC Codes and Packages
Each Xtandi 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 |
|---|---|---|---|
| 00469-0125-99 | ENZALUTAMIDE 40 mg/1 capsule | bottle of 120 capsules | Astellas Pharma US, Inc. |
| 00469-0125-99 | ENZALUTAMIDE 40 mg/1 capsule | bottle of 120 capsules | Astellas Pharma US, Inc. |
| 00469-1125-56 | ENZALUTAMIDE 40 mg/1 capsule | blister pack of 56 capsules | Astellas Pharma US, Inc. |
| 00469-1125-56 | ENZALUTAMIDE 40 mg/1 capsule | blister pack of 56 capsules | Astellas Pharma US, Inc. |
| 00469-0625-99 | ENZALUTAMIDE 40 mg/1 tablet | bottle of 120 tablets | Astellas Pharma US, Inc. |
| 00469-0625-99 | ENZALUTAMIDE 40 mg/1 tablet | bottle of 120 tablets | Astellas Pharma US, Inc. |
| 00469-1725-56 | ENZALUTAMIDE 40 mg/1 tablet | bottle of 56 tablets | Astellas Pharma US, Inc. |
| 00469-1725-56 | ENZALUTAMIDE 40 mg/1 tablet | bottle of 56 tablets | Astellas Pharma US, Inc. |
| 00469-0725-60 | ENZALUTAMIDE 80 mg/1 tablet | bottle of 60 tablets | Astellas Pharma US, Inc. |
| 00469-0725-60 | ENZALUTAMIDE 80 mg/1 tablet | bottle of 60 tablets | Astellas Pharma US, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xtandi’s own FDA approval (NDA 203415, NDA 213674) are listed, never a generic. Some codes belong to companies that repackage Xtandi: it is the same medicine in a different package.
What a Generic Xtandi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xtandi 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 Xtandi”. 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 Xtandi
Is there a generic for Xtandi right now?
No. As of October 9, 2026 no generic enzalutamide is listed for sale in the FDA NDC Directory. 4 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Xtandi go generic?
July to September 2027 is the expected window, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to February 2037, 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.
Will generic enzalutamide be the same as Xtandi?
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. 8 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 Xtandi?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in May 2021: Sandoz Inc. 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 Xtandi patent expire?
The FDA Orange Book lists 7 patents for Xtandi; the last runs to February 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 window on this page (July to September 2027) weighs all of that.
Has anyone challenged the Xtandi patents?
Yes. The first patent challenge to Xtandi reached the FDA in August 2016, from 3 companies on that first day. The FDA approved a first challenger’s generic in May 2021, 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 July to September 2027 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
- InrebicFedratinib Hydrochloride2033 to 2034
- DificidFidaxomicinNovember 2034
- RyteloImetelstat2036 to 2037
- Norepinephrine Bitartrate in Sodium ChlorideNorepinephrine BitartrateJanuary 2038
- VeregenSinecatechinsTBD no date yet
- AktenLidocaine HydrochlorideTBD no date yet
About Xtandi
- Generic name enzalutamide
- How it is taken By mouth
- Company Astellas Pharma US Inc
- Patent challenges Since August 2016 (FDA)
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xtandi
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.