Erleada Generic: When Will Generic Apalutamide 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
Erleada Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2035 to 2036 A wide window Why then?
- Has the FDA approved a generic? March 2025 1 company approved Why not on sale?
- When does the last patent end? January 2041 14 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 apalutamide is expected to be available between 2035 and 2036. None is for sale yet.
Why 2035 to 2036?
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 Erleada’s last patent runs to January 2041, how can a generic come sooner?
The 4 patents that run past the expected month, to January 2041 (10,702,508, 11,963,952, 12,303,497 and 11,723,898), cover 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 Erleada’s patents with the FDA since February 2022. 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 March 2025, 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. 7 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 Erleada 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.
Erleada 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
- Very strong 7 companies have filed, 6 first in line
- Brand sales
- $2.6B a yearBlockbuster
- FDA approved 2018 February 2018 FDA Orange Book
- Patents listed 14 last runs to January 2041 A generic is expected sooner, between 2035 and 2036. See why FDA Orange Book
- Generics FDA-approved 1 company, approved March 2025 FDA Orange Book
- Medicare Part D spent $2.1B in 2025, for 19.2K people CMS Part D Spending by Drug
- Medicaid prescriptions 2,580 in the last four reported quarters, $39.4M CMS Medicaid drug utilization, to Q1 2026
Erleada’s Road to a Generic
Erleada has had the market to itself since the FDA approved it in February 2018 (Janssen Biotech Inc). Its 14 listed patents run to January 2041. Generic companies have challenged its patents with the FDA since February 2022.
The first generic of Erleada is expected between 2035 and 2036.
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 January 2041
The last listed patent runs to January 2041, but it covers 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.
Erleada Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Erleada’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 |
|---|---|---|---|
| 8,802,689 | A way of using it (U-2237, U-2624) | March 2027 | Active |
| 9,388,159 | The active ingredient; the product’s formulation | March 2027 | Active |
| 9,987,261 | The product’s formulation | March 2027 | Active |
| 8,445,507 | The active ingredient; the product’s formulation; a way of using it (U-2624, U-2237) | February 2032 | Active |
| 9,481,663 | The active ingredient; the product’s formulation; a way of using it (U-2624, U-2237) | June 2033 | Active |
| 9,884,054 | A way of using it (U-2237) | September 2033 | Active |
| 10,849,888 | A way of using it (U-3013) | September 2033 | Active |
| RE49353 | A way of using it (U-2381) | September 2033 | Active |
| RE50642 | A way of using it (U-4450) | September 2033 | Active |
| 12,303,493 | The product’s formulation | December 2035 | Active |
| 10,702,508 | A way of using it (U-3012) | April 2038 | Active |
| 11,963,952 | A way of using it (U-3901) | January 2040 | Active |
| 12,303,497 | A way of using it (U-4448, U-4494) | January 2040 | Active |
| 11,723,898 | A way of using it (U-4449) | January 2041 | Active |
Source: FDA Orange Book, application 210951. Patent numbers open the patent on Google Patents.
Patent Challenges to Erleada
The first patent challenge to Erleada reached the FDA in February 2022, from 5 companies on that first day. The FDA’s list has 2 entries for Erleada, by form and strength. The FDA approved a first challenger’s generic in March 2025, 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 Erleada’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, 60 mg | February 2022 | 5 companies | First challenger eligible decided March 2025 | March 2025 | Not yet | April 2038 |
| Tablets, 240 mg | March 2025 | 1 company | No decision yet | Not yet | Not yet | January 2040 |
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 Apalutamide
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
7 companies have applied to the FDA to make generic apalutamide.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 6 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 Erleada’s patents with the FDA since February 2022: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in March 2025. 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 apalutamide for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Zydus Lifesciences Global Fze | March 2025 | 60MG | AB |
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).
Erleada 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 Erleada, 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 Erleada
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 Erleada, before manufacturer rebates.
- $536.6M
- January to March 2026, the latest CMS has posted
For 14,561 people, about $15,010 per prescription fill - $2.1B
- 2025, the whole year
For 19,179 people, about $14,739 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $536,604,150 | 14,561 | $15,009.91 |
| 2025 | $2,076,487,663 | 19,179 | $14,739.20 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Erleada only, so no generic is counted in it. What CMS says it is used for: Apalutamide is used to treat men with prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone).
Medicaid Prescriptions by Quarter
2,580 prescriptions in the four quarters to Q1 2026, $39.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 407 | $6,388,015 |
| Q4 2025 | 747 | $11,397,276 |
| Q3 2025 | 736 | $11,168,803 |
| Q2 2025 | 690 | $10,423,923 |
| Q1 2025 | 687 | $10,386,366 |
Source: CMS Medicaid State Drug Utilization Data, over Erleada’s own package codes.
Erleada Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 60MG | Tablet | Oral | February 2018 | Prescription reference product |
| 240MG | Tablet | Oral | February 2023 | Prescription reference product |
Source: FDA Orange Book, Janssen Biotech Inc. Listed for sale today by Janssen Products, LP (FDA NDC Directory).
Erleada NDC Codes and Packages
Each Erleada 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 |
|---|---|---|---|
| 59676-0604-14 | APALUTAMIDE 240 mg/1 tablet, film coated | blister pack of 14 tablets | Janssen Products, LP |
| 59676-0604-14 | APALUTAMIDE 240 mg/1 tablet, film coated | blister pack of 14 tablets | Janssen Products, LP |
| 59676-0604-30 | APALUTAMIDE 240 mg/1 tablet, film coated | bottle of 30 tablets | Janssen Products, LP |
| 59676-0604-30 | APALUTAMIDE 240 mg/1 tablet, film coated | bottle of 30 tablets | Janssen Products, LP |
| 59676-0600-12 | APALUTAMIDE 60 mg/1 tablet, film coated | bottle of 120 tablets | Janssen Products, LP |
| 59676-0600-12 | APALUTAMIDE 60 mg/1 tablet, film coated | bottle of 120 tablets | Janssen Products, LP |
| 59676-0600-56 | APALUTAMIDE 60 mg/1 tablet, film coated | carton of 2 blister packs of 28 tablets | Janssen Products, LP |
| 59676-0600-56 | APALUTAMIDE 60 mg/1 tablet, film coated | carton of 2 blister packs of 28 tablets | Janssen Products, LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Erleada’s own FDA approval (NDA 210951) are listed, never a generic. Some codes belong to companies that repackage Erleada: it is the same medicine in a different package.
What a Generic Erleada Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Erleada 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 Erleada”. 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 Erleada
Is there a generic for Erleada right now?
No. As of October 9, 2026 no generic apalutamide is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Erleada go generic?
2035 to 2036 is the expected window, and that is probable 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 January 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic apalutamide be the same as Erleada?
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. 7 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 Erleada?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in March 2025: Zydus Lifesciences Global Fze. 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 Erleada patent expire?
The FDA Orange Book lists 14 patents for Erleada; the last runs to January 2041. 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 (2035 to 2036) weighs all of that.
Has anyone challenged the Erleada patents?
Yes. The first patent challenge to Erleada reached the FDA in February 2022, from 5 companies on that first day. The FDA approved a first challenger’s generic in March 2025, 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 2035 to 2036 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
- Cubicin RFDaptomycin2026 to 2027
- ValchlorMechlorethamine HydrochlorideJuly 2029
- NatestoTestosteroneMarch 2034
- ZynrelefBupivacaine and MeloxicamApril 2036
- IcotydeIcotrokinraDuring 2041
- RezdiffraResmetirom2042 to 2043
About Erleada
- Generic name apalutamide
- How it is taken By mouth
- Company Janssen Biotech Inc
- Patent challenges Since February 2022 (FDA)
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Erleada
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.