KERENDIA Drug Patent Profile

Which patents cover Kerendia, and when can generic versions of Kerendia launch?

Kerendia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in KERENDIA is finerenone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the finerenone profile page.

DrugPatentWatch^® Generic Entry Outlook for Kerendia

Kerendia was eligible for patent challenges on July 9, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 29, 2035. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (finerenone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for KERENDIA

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	6
Patent Applications:	296
Drug Prices:	Drug price information for KERENDIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KERENDIA
What excipients (inactive ingredients) are in KERENDIA?	KERENDIA excipients list
DailyMed Link:	KERENDIA at DailyMed

See drug prices for KERENDIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KERENDIA

NDA:

215341

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KERENDIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boehringer Ingelheim	Phase 4
University Medical Center Groningen	Phase 4
University of North Carolina, Chapel Hill	Phase 2

See all KERENDIA clinical trials

Pharmacology for KERENDIA

Drug Class	Nonsteroidal Mineralocorticoid-Receptor Antagonist
Mechanism of Action	Mineralocorticoid Receptor Antagonists

Paragraph IV (Patent) Challenges for KERENDIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KERENDIA	Tablets	finerenone	40 mg	215341	1	2026-02-02
KERENDIA	Tablets	finerenone	10 mg and 20 mg	215341	9	2025-07-09

US Patents and Regulatory Information for KERENDIA

KERENDIA is protected by two US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No			Y	Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-003	Jul 11, 2025		RX	Yes	Yes

EU/EMA Drug Approvals for KERENDIA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Kerendia	finerenone	EMEA/H/C/005200Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.	Authorised	no	no	no	2022-02-16

International Patents for KERENDIA

When does loss-of-exclusivity occur for KERENDIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

Chile

China

Colombia

Croatia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KERENDIA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	065463
Australia	2008221071
Brazil	122020008544
Brazil	PI0808098

Supplementary Protection Certificates for KERENDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	C02132206/01	Switzerland		PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
2132206	LUC00260	Luxembourg		PRODUCT NAME: FINERENONE, SES SELS ET SOLVATES AINSI QUE LES SOLVATES DES SELS DE FINERENONE; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217
2132206	PA2022512	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	122022000030	Germany		PRODUCT NAME: FINERENON, SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; AUTHORISATION NO/DATE: EU/1/21/1616 20220216

Kerendia Market Dynamics, Patent Exclusivity, and Financial Trajectory

Last updated: September 10, 2026

Kerendia, Bayer’s finerenone product, is a commercially important nonsteroidal mineralocorticoid receptor antagonist for adults with chronic kidney disease associated with type 2 diabetes. U.S. sales expanded rapidly after launch, supported by cardiovascular and renal outcome data, a large eligible population, and treatment guidelines that increasingly position finerenone alongside SGLT2 inhibitors and GLP-1 therapies. Its principal commercial risk is delayed prescribing adoption rather than immediate generic erosion. U.S. small-molecule exclusivity ends in 2026, while key patent protection is expected to extend into the early 2030s.

What is Kerendia and how does finerenone work?

Kerendia contains finerenone, a selective, nonsteroidal mineralocorticoid receptor antagonist. Bayer markets it for adults with chronic kidney disease associated with type 2 diabetes to reduce the risk of sustained estimated glomerular filtration rate decline, kidney failure, nonfatal cardiovascular events, and cardiovascular death.

Finerenone differs from spironolactone and eplerenone because it is nonsteroidal and has a different tissue distribution and receptor-binding profile. Its commercial value depends on reducing residual renal and cardiovascular risk after treatment with renin-angiotensin system inhibitors.

The FDA approved Kerendia on July 9, 2021, based principally on the FIDELIO-DKD trial. The FIGARO-DKD trial later supplied cardiovascular-outcome evidence. The FDA label requires potassium and renal-function assessment because hyperkalemia is the main treatment-limiting safety issue. (U.S. Food and Drug Administration [FDA], 2021)

Product	Active ingredient	Drug class	Primary approved U.S. use through 2024	Sponsor
Kerendia	Finerenone	Nonsteroidal MRA	CKD associated with type 2 diabetes	Bayer
Aldactone	Spironolactone	Steroidal MRA	Heart failure, hypertension, hyperaldosteronism and other uses	Pfizer
Inspra	Eplerenone	Steroidal MRA	Heart failure and hypertension	Pfizer
Farxiga/Jardiance	Dapagliflozin/empagliflozin	SGLT2 inhibitor	CKD, heart failure, diabetes and related indications	AstraZeneca/Eli Lilly and Boehringer Ingelheim

How large is the Kerendia market?

The addressable population is large because type 2 diabetes is a leading cause of chronic kidney disease. Many patients remain at risk despite treatment with an ACE inhibitor or angiotensin receptor blocker. The commercial opportunity is constrained by three factors:

1. Finerenone is indicated for a defined CKD and diabetes population, not all patients with diabetes.
2. SGLT2 inhibitors compete for clinical attention and can be prescribed earlier in the treatment pathway.
3. Prescribers must monitor serum potassium and kidney function.

The product’s strongest commercial segment is patients with persistent albuminuria and diabetic kidney disease who remain at elevated renal and cardiovascular risk after standard background therapy.

Kerendia market drivers

Clinical and commercial growth has been supported by:

• Positive renal outcomes in FIDELIO-DKD.
• Cardiovascular outcome benefits in FIGARO-DKD.
• A differentiated mechanism relative to steroidal MRAs.
• Guideline recognition of finerenone as an option for eligible patients with diabetic CKD.
• Increased screening for albuminuria and earlier CKD diagnosis.
• Expansion of treatment beyond specialist nephrology and cardiology practices.
• Potential future use in heart failure and broader CKD populations if regulatory approvals are obtained.

Kerendia market barriers

The main barriers are:

• Hyperkalemia monitoring.
• Prescriber familiarity with SGLT2 inhibitors.
• Payer step edits and utilization management.
• Limited direct evidence supporting every possible combination with newer diabetes and heart-failure drugs.
• Competition from low-cost generic spironolactone and eplerenone.
• The need to identify albuminuric CKD patients through laboratory testing.

What has Kerendia’s financial trajectory been?

Bayer has reported strong percentage growth from a small launch base. Public Bayer reporting placed Kerendia sales at approximately €284 million in 2023, up materially from the preceding year. The product remained smaller than Bayer’s major franchises, including Xarelto, Eylea, and Nubeqa, but it was one of the company’s more important growth products. (Bayer AG, 2024)

Period	Commercial status	Financial interpretation
2021	U.S. launch after FDA approval	Initial sales limited by market education and renal prescribing adoption
2022	Early market expansion	Reimbursement, guideline adoption, and FIDELIO/FIGARO evidence supported growth
2023	Approximately €284 million in Bayer-reported sales	Product moved from launch phase toward scale-up
2024 onward	Expansion depends on uptake, label growth, and geographic execution	The commercial trajectory remains sensitive to SGLT2 competition and payer restrictions

Kerendia’s sales profile is more important strategically than its absolute contribution to Bayer’s group revenue. Bayer faces patent and loss-of-exclusivity pressure in other pharmaceutical products, particularly Xarelto and Eylea. A growing Kerendia franchise can partly offset those declines, although it cannot replace the near-term revenue scale of those products without substantial label expansion.

What could drive Kerendia sales above the current base?

The largest upside opportunities are:

• Broader adoption in diabetic CKD.
• Use with SGLT2 inhibitors where clinical evidence supports combination therapy.
• More aggressive albuminuria screening.
• Cardiovascular prescribing after additional heart-failure data.
• Expansion into non-diabetic CKD if clinical development and regulatory review are successful.
• International reimbursement improvements.

The FINEARTS-HF study reported positive results in heart failure with mildly reduced or preserved ejection fraction. Bayer stated that finerenone reduced the composite risk of cardiovascular death and total heart-failure events in the study population. The data created a potential second major commercial indication, although the economic value depends on the final label, payer positioning, and competition from SGLT2 inhibitors and other heart-failure medicines. (Bayer AG, 2024)

When does Kerendia lose regulatory exclusivity?

Kerendia’s five-year new chemical entity exclusivity is expected to expire in July 2026, based on the FDA approval date of July 9, 2021. NCE exclusivity prevents the FDA from approving an ANDA that relies on the reference product’s full approval package during the protected period. It does not itself prevent all patent challenges or all competing products.

Exclusivity or protection	Estimated timing	Commercial effect
FDA five-year NCE exclusivity	July 2026	Earliest standard ANDA approval timing based on NCE protection
Pediatric exclusivity	No established extension identified in the cited public sources	Would add six months only if granted
Key U.S. patent protection	Expected into the early 2030s	Main barrier to commercial generic launch
Regulatory exclusivity outside the U.S.	Varies by jurisdiction	Depends on local approval and patent rules

A generic company could file an ANDA before NCE expiration using a Paragraph IV certification against listed patents. FDA approval and commercial launch would still depend on the litigation outcome, settlement terms, patent validity, and any agreed launch date.

What patents protect Kerendia?

Kerendia is protected by a combination of compound, pharmaceutical-composition, treatment-method, and potentially formulation or solid-state patents. The exact Orange Book listing controls the U.S. patent certifications required for an ANDA applicant.

The strongest commercial protection is generally the patent estate covering finerenone and its use in treating CKD associated with type 2 diabetes. Method-of-use claims can be particularly important because they may cover the labeled patient population even when a generic applicant attempts to carve out a patented indication.

What is the Orange Book status of Kerendia?

FDA’s Orange Book identifies patents and regulatory exclusivities associated with approved drug products. Kerendia’s listed protection should be assessed through the FDA’s current Drugs@FDA and Orange Book databases because patent listings can change through corrections, new grants, pediatric extensions, or litigation-related updates. (FDA, n.d.-a; FDA, n.d.-b)

The commercial implications are straightforward:

• A Paragraph IV filing can trigger patent litigation.
• A Paragraph III certification can defer approval until patent expiration.
• A section viii statement may permit approval for non-patented uses if the labeling carve-out is acceptable.
• A patent listing does not establish validity or enforceability.
• A settlement can produce an authorized-generic, delayed-entry, or license arrangement.

Publicly available information through 2024 did not establish a major U.S. generic launch against Kerendia. The absence of a visible launch does not remove future Paragraph IV risk once NCE exclusivity expires.

What generic entry risks exist for Kerendia?

The most credible generic entry window begins after July 2026, subject to the listed patent estate. A successful Paragraph IV challenge could move entry earlier than the latest patent expiry. A settlement could produce an agreed launch date before patent expiration, but the terms would determine whether the entrant is a conventional generic, authorized generic, or licensee.

Generic launch scenarios

Scenario	Likely timing	Market impact
No successful challenge	Early 2030s or later	Bayer retains branded pricing protection until patent expiry
Paragraph IV settlement	Contract-specific	Earlier entry may occur with limited or staged competition
Patent invalidity or non-infringement ruling	Before patent expiry	Rapid price erosion and payer substitution risk
Authorized generic launch	Contract-specific	Bayer may preserve part of the economics while controlling erosion
Carved-out indication	After ANDA approval	Initial competition may be limited if key use claims remain protected

Finerenone is a small molecule, so biosimilar risk does not apply. The relevant threat is ordinary generic competition under the ANDA pathway. Manufacturing complexity is likely lower than for a biologic, although control of polymorph, particle-size distribution, impurity profile, dissolution, and stability can affect development and regulatory equivalence.

Which companies are challenging Kerendia?

No major U.S. generic challenger had established commercial market presence in the public information considered through 2024. Potential challengers would include large generic manufacturers such as Teva, Sandoz, Viatris, Sun Pharma, Lupin, Dr. Reddy’s, and Zydus, but company-specific Paragraph IV activity should not be inferred without an FDA filing, court docket, or formal litigation record.

The competitive threat is therefore divided between future generic entrants and branded therapeutic alternatives. SGLT2 inhibitors are the most significant branded competitors because they address overlapping diabetic CKD and heart-failure populations. Spironolactone and eplerenone exert price pressure but have different evidence bases, safety profiles, and labeling.

How strong is the Kerendia patent estate?

Kerendia has a commercially meaningful patent position because:

• The product is a novel small molecule rather than an old generic compound.
• The labeled use is tied to a defined high-risk CKD population.
• Clinical-trial evidence supports method-of-use claims.
• The likely patent runway extends well beyond NCE exclusivity.
• Prescribing growth can continue during the period between NCE expiry and anticipated patent expiry.

Patent strength depends on claim scope, written description, enablement, prosecution history, prior art, Orange Book listing accuracy, and the vulnerability of method-of-use claims to a section viii carve-out. A long nominal expiry date does not guarantee enforceability.

What patent litigation and settlements affect Kerendia?

No major public settlement or final U.S. patent judgment involving a commercial Kerendia generic was established in the cited record through 2024. Litigation risk is likely to increase as NCE exclusivity approaches expiration and generic applicants begin filing ANDAs with Paragraph IV certifications.

A future dispute would likely focus on:

• Validity of finerenone compound or composition claims.
• Infringement by generic labeling.
• Scope of method-of-use claims.
• Whether a proposed indication carve-out avoids infringement.
• Patent-listing eligibility under the Orange Book.
• The timing and structure of any launch settlement.

How does Kerendia compare with SGLT2 inhibitors?

Factor	Kerendia	SGLT2 inhibitors
Mechanism	Nonsteroidal mineralocorticoid receptor antagonism	Increased urinary glucose and sodium excretion
Core opportunity	Diabetic CKD with albuminuria and residual risk	Diabetes, CKD, heart failure and cardiovascular-risk reduction
Main safety issue	Hyperkalemia	Genital infections, volume depletion and other class-specific effects
Monitoring	Potassium and renal function	Renal function, volume status and tolerability
Generic risk	After patent and exclusivity barriers	Varies by molecule and jurisdiction
Commercial positioning	Add-on or complementary therapy	Often earlier-line cardiorenal therapy

Combination treatment is commercially important. If clinicians use finerenone after or alongside SGLT2 inhibitors, the products may be complementary rather than directly substitutable. That positioning would expand the treated population but could also increase payer demands for evidence and step therapy.

What is Kerendia’s geographic coverage?

Bayer markets finerenone in multiple jurisdictions under the Kerendia or regional product name, subject to local approvals. U.S. revenue remains strategically important because of the size of the CKD market and the concentration of specialty prescribing. European and other international markets contribute incremental growth but face country-specific reimbursement negotiations and reference-pricing pressure.

Patent duration, regulatory exclusivity, reimbursement, and generic filing practices differ by country. The U.S. patent and Orange Book position should not be used as a proxy for European, Japanese, Chinese, or emerging-market protection.

Key Takeaways

• Kerendia is Bayer’s finerenone product for CKD associated with type 2 diabetes.
• FDA approval occurred in July 2021.
• U.S. five-year NCE exclusivity is expected to expire in July 2026.
• Key patent protection is expected to extend into the early 2030s, subject to validity, enforcement, and listing status.
• Bayer reported approximately €284 million in Kerendia sales for 2023.
• The primary commercial growth drivers are diabetic CKD penetration, albuminuria screening, combination use with SGLT2 inhibitors, and potential heart-failure expansion.
• The principal near-term risks are hyperkalemia monitoring, payer controls, SGLT2 competition, and future Paragraph IV litigation.
• Kerendia faces generic, not biosimilar, risk.
• The FINEARTS-HF results create a potential expansion path beyond the current diabetic CKD market.
• Patent litigation or settlement activity is likely to become more material as the 2026 NCE expiry approaches.

FAQs

Is Kerendia a biologic or a small-molecule drug?

Kerendia is a small-molecule drug containing finerenone. It is eligible for generic competition through the ANDA pathway, not biosimilar competition.

Can generic finerenone launch in 2026?

NCE exclusivity is expected to end in July 2026, but generic launch also depends on listed patents, Paragraph IV litigation, settlements, and any court-ordered injunction.

Does Kerendia have orphan-drug exclusivity?

Kerendia was approved for a broad diabetic CKD population and is not generally treated as an orphan-drug product. Its principal regulatory protection is NCE exclusivity, supported by patent rights.

Is finerenone approved for all forms of heart failure?

Through the cited 2024 record, Kerendia’s established U.S. indication was diabetic CKD. Positive FINEARTS-HF results created a potential heart-failure expansion, but commercial use in a new indication depends on FDA approval and labeling.

What is the biggest financial risk to Bayer’s Kerendia forecast?

The largest risk is slower-than-expected adoption in the eligible diabetic CKD population because of SGLT2 inhibitor competition, hyperkalemia monitoring, payer restrictions, and delayed uptake by primary-care prescribers.

References

Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/annual-reports

Bayer AG. (2024). Bayer’s FINEARTS-HF study with finerenone meets primary endpoint in patients with heart failure and mildly reduced or preserved ejection fraction. https://www.bayer.com/en/media

U.S. Food and Drug Administration. (2021). FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes. https://www.fda.gov/news-events/press-announcements

U.S. Food and Drug Administration. (n.d.-a). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

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