Kerendia Generic: When Will Generic Finerenone 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
Kerendia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2033 About 7 years away Why then?
- Has the FDA approved a generic? Not yet 1 company holds a tentative approval Why not yet?
- When does the last patent end? July 2035 2 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 finerenone is expected to be available in August 2033, about 7 years away. None is for sale yet.
Why August 2033?
It is when Kerendia’s patent 8,436,180 ends. That patent covers the active ingredient and the product’s formulation, 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 Kerendia’s last patent runs to July 2035, how can a generic come sooner?
The patent that runs to July 2035 (RE49826) covers the active ingredient. 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 Kerendia’s patents with the FDA since July 2025. 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. One company already holds a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Apotex Inc (August 2026). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 9 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, which would take the $22.86 pharmacies pay per tablet for Kerendia today to under $1.14. See the price estimate
What should I do now?
Keep taking Kerendia 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.
Kerendia 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
- Very strong 9 companies have filed, 9 first in line
- Brand sales
- $882M a yearBig seller
- FDA approved 2021 July 2021 FDA Orange Book
- Patents listed 2 last runs to July 2035 A generic is expected sooner, in August 2033. See why FDA Orange Book
- Pharmacies pay $22.86 per tablet, up 8.6% in a year NADAC, October 2026
- Medicare Part D spent $589.4M in 2025, for 121.8K people CMS Part D Spending by Drug
- Medicaid prescriptions 70.1K in the last four reported quarters, $60.7M CMS Medicaid drug utilization, to Q1 2026
Kerendia’s Road to a Generic
Kerendia has had the market to itself since the FDA approved it in July 2021 (Bayer Healthcare Pharmaceuticals Inc). Its FDA protection (new strength) runs to July 2028. Its 2 listed patents run to July 2035. Generic companies have challenged its patents with the FDA since July 2025.
The first generic of Kerendia is expected in August 2033.
Why that month: patent 8,436,180, on the active ingredient and the product’s formulation, ends then. That is about 2 years before the last listed patent runs out, in July 2035.
Why a Generic Can Come Before July 2035
The last listed patent runs to July 2035; 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.
Kerendia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Kerendia’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 8,436,180, which ends in August 2033, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,436,180 Sets the expected month of generic availability | The active ingredient; the product’s formulation | August 2033 | Active |
| RE49826 | The active ingredient | July 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | July 2026 | Ended |
| New use I-970 | Three years of protection for a newly approved use (indication). | July 2028 | Active |
| New strength NS | Three years of protection for a new strength. | July 2028 | Active |
Source: FDA Orange Book, application 215341. Patent numbers open the patent on Google Patents.
Patent Challenges to Kerendia
The first patent challenge to Kerendia reached the FDA in July 2025, from 9 companies on that first day. The FDA’s list has 2 entries for Kerendia, by form and strength. 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 Kerendia’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, 10 mg and 20 mg | July 2025 | 9 companies | No decision yet | Not yet | Not yet | July 2035 |
| Tablets, 40 mg | February 2026 | 1 company | No decision yet | Not yet | Not yet | July 2035 |
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 Finerenone
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
9 companies have applied to the FDA to make generic finerenone.
The FDA has tentatively approved one company’s generic: Apotex Inc (August 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. 9 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 Kerendia’s patents with the FDA since July 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic finerenone. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic finerenone 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).
Kerendia Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Kerendia 10 mg tablet
$22.86 per tablet in October 2026, up 8.6% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Kerendia 10 mg tablet $22.86 per tablet
- Kerendia 20 mg tablet $22.85 per tablet
- Kerendia 40 mg tablet $22.86 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $22.86 |
| September 2026 | $22.86 |
| August 2026 | $22.85 |
| July 2026 | $22.85 |
| June 2026 | $22.85 |
| May 2026 | $22.85 |
| April 2026 | $22.87 |
| March 2026 | $22.87 |
| February 2026 | $22.87 |
| January 2026 | $22.87 |
| February 2024 | $21.04 |
| January 2024 | $21.04 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Kerendia today: $22.86 per tablet for Kerendia 10 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Kerendia has 9 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $22.86 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Kerendia
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 Kerendia, before manufacturer rebates.
- $174.6M
- January to March 2026, the latest CMS has posted
For 95,440 people, about $1,023 per prescription fill - $589.4M
- 2025, the whole year
For 121,794 people, about $978 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $174,617,111 | 95,440 | $1,022.62 |
| 2025 | $589,416,424 | 121,794 | $978.24 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Kerendia only, so no generic is counted in it. What CMS says it is used for: Finerenone is used by people with type 2 diabetes and kidney disease to lower the risk of dialysis, death from heart disease, heart attacks, and the need to go to the hospital for heart failure.
Medicaid Prescriptions by Quarter
70,123 prescriptions in the four quarters to Q1 2026, $60.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 7,145 | $6,392,138 |
| Q4 2025 | 21,537 | $18,702,998 |
| Q3 2025 | 22,256 | $19,244,145 |
| Q2 2025 | 19,185 | $16,316,399 |
| Q1 2025 | 18,606 | $15,886,281 |
Source: CMS Medicaid State Drug Utilization Data, over Kerendia’s own package codes.
Kerendia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG | Tablet | Oral | July 2021 | Prescription reference product |
| 20MG | Tablet | Oral | July 2021 | Prescription reference product |
| 40MG | Tablet | Oral | July 2025 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer Healthcare Pharmaceuticals Inc. (FDA NDC Directory).
Kerendia NDC Codes and Packages
Each Kerendia 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 |
|---|---|---|---|
| 50419-0540-01 | FINERENONE 10 mg/1 tablet, film coated | bottle of 30 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-01 | FINERENONE 10 mg/1 tablet, film coated | bottle of 30 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-02 | FINERENONE 10 mg/1 tablet, film coated | bottle of 90 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-02 | FINERENONE 10 mg/1 tablet, film coated | bottle of 90 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-06 | FINERENONE 10 mg/1 tablet, film coated | blister pack of 10 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-70 | FINERENONE 10 mg/1 tablet, film coated | bottle of 7 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0540-70 | FINERENONE 10 mg/1 tablet, film coated | bottle of 7 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-01 | FINERENONE 20 mg/1 tablet, film coated | bottle of 30 tablets | Bayer HealthCare Pharmaceuticals Inc. |
Show the other 11 Kerendia packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 50419-0541-01 | FINERENONE 20 mg/1 tablet, film coated | bottle of 30 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-02 | FINERENONE 20 mg/1 tablet, film coated | bottle of 90 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-02 | FINERENONE 20 mg/1 tablet, film coated | bottle of 90 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-06 | FINERENONE 20 mg/1 tablet, film coated | blister pack of 10 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-70 | FINERENONE 20 mg/1 tablet, film coated | bottle of 7 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0541-70 | FINERENONE 20 mg/1 tablet, film coated | bottle of 7 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0542-01 | FINERENONE 40 mg/1 tablet | bottle of 30 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0542-02 | FINERENONE 40 mg/1 tablet | bottle of 90 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0542-05 | FINERENONE 40 mg/1 tablet | carton of 10 blister packs of 10 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0542-06 | FINERENONE 40 mg/1 tablet | blister pack of 10 tablets | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0542-70 | FINERENONE 40 mg/1 tablet | bottle of 7 tablets | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Kerendia’s own FDA approval (NDA 215341) are listed, never a generic. Some codes belong to companies that repackage Kerendia: it is the same medicine in a different package.
What a Generic Kerendia Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Kerendia 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 Kerendia”. 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 Kerendia
Is there a generic for Kerendia right now?
No. As of October 9, 2026 no generic finerenone is listed for sale in the FDA NDC Directory.
When will Kerendia go generic?
August 2033 is the expected month, and that is probable but not certain. It is when Kerendia’s patent 8,436,180 ends. That patent covers the active ingredient and the product’s formulation, 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 July 2035; a court ruling or a settlement can bring a generic sooner.
Will generic finerenone be the same as Kerendia?
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. 9 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, which would take the $22.86 pharmacies pay per tablet for Kerendia today to under $1.14. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Kerendia?
Not yet. The FDA Orange Book lists no approved generic version of Kerendia.
When does the Kerendia patent expire?
The FDA Orange Book lists 2 patents for Kerendia; the last runs to July 2035. The one behind the expected month is patent 8,436,180, which ends in August 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 (August 2033) weighs all of that.
Has anyone challenged the Kerendia patents?
Yes. The first patent challenge to Kerendia reached the FDA in July 2025, from 9 companies 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.
How much does Kerendia cost now?
Pharmacies paid about $22.86 per tablet for Kerendia 10 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected August 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
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- ZusduriMitomycin2036 to 2037
- UtebziTebipenem Pivoxil HydrobromideJanuary to March 2038
- RetevmoSelpercatinibApril 2039
- CrenessityCrinecerfontJune 2041
About Kerendia
- Generic name finerenone
- How it is taken By mouth
- Company Bayer Healthcare Pharmaceuticals Inc
- Patent challenges Since July 2025 (FDA)
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Kerendia
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, NADAC (CMS), 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.