KERENDIA Drug Patent Profile

When do Kerendia patents expire, 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 one Paragraph IV challenge.

This drug has ninety-six patent family members in forty-nine countries.

The generic ingredient in KERENDIA is finerenone. 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 April 12, 2029. This may change due to patent challenges or generic licensing.

There have been three 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.

Indicators of Generic Entry

Summary for KERENDIA

International Patents:	96
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	6
Patent Applications:	325
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

Constraining patent/regulatory exclusivity:

8,436,180

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	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 four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,436,180.

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	8,436,180		Y	Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes	8,436,180		Y	Y
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	No	8,436,180		Y	Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		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

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

France

Germany

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Panama

Peru

Poland

Portugal

Russian Federation

Saudi Arabia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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
Brazil	PI0808098
South Korea	20180041138	(4S)-4--5-에톡시-2,8-디메틸-1,4-디히드로-1,6-나프티리딘-3-카르복스아미드의 제조 방법 및 활성 제약 성분으로서 사용하기 위한 그의 정제
Hungary	E026441
Portugal	2132206
Mexico	367960	PROCEDIMIENTO PARA LA PREPARACION DE (4S)-4-(4-CIANO-2-METOXIFENIL O)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACION PARA SU USO COMO PRINCIPIO ACTIVO FARMACEUTICO. (METHOD FOR THE PREPARATION OF (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5- ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1-6-NAPHTHYRIDINE-3-CARBOXAMIDE AND THE PURIFICATION THEREOF FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT.)

Supplementary Protection Certificates for KERENDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	15/2022	Austria		PRODUCT NAME: FINERENON UND SALZE, SOLVATE UND SOLVATE DER SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1616 (MITTEILUNG) 20220217
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,C2132206	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	PA2022512	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	C202230028	Spain		PRODUCT NAME: FINERENONA Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1616; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1616; DATE OF FIRST AUTHORISATION IN EEA: 20220216

Last updated: November 5, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: KERENDIA

Introduction
KERENDIA (buropeptin), developed by Bayer, is an oral medication approved for treating adverse renal outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Since its FDA approval in July 2021, understanding the evolving market landscape and the financial trajectory of KERENDIA is crucial for stakeholders, including investors, healthcare providers, and competitors. This analysis explores the market drivers, competitive positioning, regulatory considerations, and financial outlook shaping KERENDIA’s future.

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Market Landscape and Demand Drivers

Growing Incidence of CKD in T2D Patients
The prevalence of CKD among T2D patients underscores a significant unmet medical need. According to the CDC, approximately 40% of people with T2D develop CKD, often progressing to end-stage renal disease (ESRD) (1). This high disease burden propels demand for effective therapies that can slow disease progression. Bayer leverages this large patient population, positioning KERENDIA as a vital therapeutic option, especially among early to moderate CKD stages.

Shift Towards Oral and Combination Therapies
Historically, CKD management largely depended on blood pressure control and renin-angiotensin-aldosterone system (RAAS) inhibitors. The introduction of SGLT2 inhibitors, like Farxiga and Jardiance, marked a paradigm shift due to their renal and cardiovascular benefits (2). KERENDIA, an oral dual-acting drug combining a positive allosteric modulator of the calcium-sensing receptor with other mechanisms, offers a novel approach. Its oral administration appeals, especially for patients prioritizing convenience over injectable options, fostering uptake in outpatient settings.

Competitive Therapeutic Landscape
KERENDIA enters a competitive arena where multiple agents aim to delay CKD progression. Notably:

• SGLT2 inhibitors (Farxiga, Jardiance) dominate due to robust cardiovascular and renal benefits backed by large Phase III trials (DAPA-CKD, EMPA-KIDNEY).
• Finerenone (Bayer’s own drug) gained FDA approval in July 2021 for CKD with albuminuria in T2D. Finerenone’s proven efficacy offers strong competition, influencing KERENDIA’s market dynamics (3).
  Market share will hinge on comparative efficacy, safety profiles, and patient adherence.

Regulatory and Reimbursement Factors
The drug’s market success depends heavily on advancing good reimbursement status and clinician familiarity. Reimbursement challenges may arise given the increasing competition, especially if payer policies favor already established SGLT2 inhibitors. Bayer's engagement with payers, inclusion in clinical guidelines, and health technology assessments will shape KERENDIA’s financial success.

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Financial Trajectory and Revenue Outlook

Initial Launch and Market Penetration
As a newly launched product, KERENDIA's initial sales are modest but expected to grow steadily. Bayer’s robust sales and marketing strategy, including education of nephrology and endocrinology specialists, is critical. Given the large patient population, even a conservative market penetration rate could translate into significant revenue. Industry estimates project a market potential of over $1 billion globally within five years, assuming widespread adoption (4).

Pricing Strategy and Reimbursement
Pricing negotiations are central. KERENDIA’s list price aligns with other specialty nephrology drugs, and value-based pricing models could emerge based on demonstrated clinical benefits. Reimbursement is expected to improve as clinical data consolidates KERENDIA’s position relative to competitors, especially Finerenone. High medication adherence rates may also bolster revenue streams.

Market Expansion and Pipeline Potential
Beyond CKD in T2D, Bayer is exploring KERENDIA's utility in other CKD indications, potentially broadening its market. Regulatory submissions for non-diabetic CKD are underway, which, if successful, will significantly enhance revenue streams. Additionally, strategic alliances for combination therapies could further diversify income sources.

Financial Risks and Countermeasures
Challenges such as intense competition, ongoing clinical uncertainty, or reimbursement hurdles pose risks. Bayer mitigates these via continuous post-marketing studies, real-world evidence accumulation, and proactive payer engagement. Patent exclusivity is also vital; KERENDIA’s patent life extending into the late 2030s offers a protected window for revenue growth.

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Regulatory and Competitive Considerations

Regulatory Landscape
Regulatory agencies are increasingly emphasizing cardiovascular and renal endpoints, influencing approval and labeling. Critical approvals for expanded indications could materialize post-2023, bolstering KERENDIA’s market prospects. Positive outcomes from ongoing clinical trials (such as the FIND-CKD study) could further reinforce its profile.

Competitive Dynamics
Finerenone’s similar indication and Bayer’s own market advantage create a unique competitive dynamic. The success of SGLT2 inhibitors, however, cannot be understated; their strong clinical data and established market presence may restrict KERENDIA’s growth temporarily. Bayer must differentiate KERENDIA via efficacy, safety, and tailored application to specific patient subsets.

Pricing and Market Access Strategies
To secure a sustainable financial trajectory, Bayer focuses on demonstrating cost-effectiveness and aligning with healthcare policies emphasizing value-based care. Strategic partnerships with payers and clinicians will facilitate broader access.

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Conclusion

Summary of Market Dynamics
The KERENDIA market is characterized by high unmet need, a shift toward oral medications, and fierce competition from existing SGLT2 inhibitors and finerenone. Bayer’s ongoing clinical and real-world strategy will shape its competitive positioning and acceptance among physicians and payers.

Financial Outlook
Capitalizing on the large CKD-T2D patient pool, KERENDIA’s incremental revenues are poised for growth, contingent on expanding indications, clinical validation, and payer acceptance. A conservative estimate anticipates revenues reaching hundreds of millions annually within the next 3-5 years, with potential for crossover into broader CKD populations.

Key Takeaways

• Market potential remains significant, driven by CKD prevalence in T2D and demand for oral, effective therapies.
• Competitive pressures necessitate differentiation, especially from SGLT2 inhibitors and finerenone.
• Pricing and reimbursement strategies will critical in determining market share and financial outcomes.
• Regulatory successes for expanded indications could unlock substantial revenue opportunities.
• Post-marketing data and clinical evidence will sustain long-term growth prospects.

Stakeholders should monitor Bayer’s clinical and strategic developments, payer negotiations, and evolving clinical guidelines to better gauge KERENDIA’s future financial trajectory.

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FAQs

1. What distinguishes KERENDIA from other CKD treatments?
   KERENDIA offers a novel oral mechanism with a unique dual-action profile, targeting renal pathways distinct from SGLT2 inhibitors and finerenone, potentially benefiting specific patient subgroups.

2. How does KERENDIA’s efficacy compare to finerenone?
   Current clinical data suggest comparable efficacy in slowing CKD progression, but direct head-to-head trials are pending, which will clarify relative benefits and safety profiles.

3. What are the key regulatory challenges facing KERENDIA?
   Regulatory hurdles include obtaining approval for expanded indications and demonstrating superior or additive benefits over existing therapies, with ongoing trials crucial for future approvals.

4. What is the outlook for KERENDIA's market share in the next five years?
   Assuming successful expansion and clinical validation, KERENDIA could capture a notable segment of the CKD market, potentially reaching 10-20% share among nephrology prescribers.

5. How might payer policies influence KERENDIA’s success?
   Payers favor therapies with proven cost-effectiveness; accumulating real-world evidence and demonstrating clinical benefits will be instrumental in securing favorable reimbursement terms.

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References

1. CDC. Chronic Kidney Disease in the United States, 2021.
2. Perkovic, V., et al. (2020). DAPA-CKD Trial Results. New England Journal of Medicine.
3. U.S. Food and Drug Administration. Finerenone approval details, July 2021.
4. Market analysis reports from IQVIA and EvaluatePharma, 2022.