Finerenone - Generic Drug Details

What are the generic drug sources for finerenone and what is the scope of patent protection?

Finerenone is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for finerenone

International Patents:	96
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	48
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for finerenone
What excipients (inactive ingredients) are in finerenone?	finerenone excipients list
DailyMed Link:	finerenone at DailyMed

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

Constraining patent/regulatory exclusivity:

8,436,180

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 finerenone

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

Sponsor	Phase
University Medical Center Groningen	PHASE3
Sarfez Pharmaceuticals, Inc.	PHASE3
Washington D.C. Veterans Affairs Medical Center	PHASE4

See all finerenone clinical trials

Pharmacology for finerenone

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

Anatomical Therapeutic Chemical (ATC) Classes for finerenone

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for FINERENONE

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 finerenone

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	215341-002	Jul 9, 2021		RX	Yes	Yes
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	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	No	RE49826			Y

EU/EMA Drug Approvals for finerenone

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 finerenone

Country	Patent Number	Title	Estimated Expiration
Japan	5752754
Israel	200060
Cyprus	1116455
Malaysia	195226	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 finerenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	22C1017	France		PRODUCT NAME: FINERENONE ET SES SELS, SOLVATES ET SOLVATES DES SELS.; REGISTRATION NO/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; 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

Market Dynamics and Financial Trajectory for Finereneone

Last updated: December 12, 2025

Executive Summary

Finereneone, an emerging pharmaceutical agent, is gaining attention within cardiovascular and metabolic therapeutic markets. As a novel selective mineralocorticoid receptor antagonist (MRA), it is positioned for potential growth due to its optimized pharmacokinetics, reduced side effects compared to existing MRAs, and expanding indications. This report provides a comprehensive analysis of its market dynamics, competitive landscape, regulatory pathway, and financial trajectory, equipping stakeholders with strategic insights into its commercial potential.

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What Is Finereneone?

Finereneone is an experimental or recently developed pharmaceutical compound—here, designated as a potent, selective MRA. Its primary targeted indications include hypertension, heart failure, and potentially, resistant hypertension—areas currently dominated by drugs like spironolactone and eplerenone.

Key specifications:

Parameter	Detail
Therapeutic class	Mineralocorticoid receptor antagonist (MRA)
Mechanism	Selective blockade of mineralocorticoid receptors
Expected advantages	Reduced hyperkalemia, fewer endocrine side effects
Phase	Clinical development (assumed Phase 2/3)
Estimated launch	2025-2026 (projected)

Note: As of the latest available data, specific clinical trial outcomes and regulatory submissions are pending or ongoing.

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How Do Market Dynamics Shape Finereneone’s Trajectory?

What Are the Key Market Drivers?

• Rising prevalence of hypertension and heart failure: According to the WHO, >1.3 billion adults globally suffer from hypertension, with a significant subset exhibiting resistant hypertension—often treated with MRAs [1].

• Limitations of existing therapies: Spironolactone and eplerenone are effective but limited by adverse events like hyperkalemia and endocrine effects, prompting demand for safer alternatives.

• Advancements in drug specificity: Finereneone’s selectivity promises safety improvements, bolstering adoption potential.

• Regulatory trends favoring novel therapies: Agencies like FDA and EMA prioritize innovative treatments with improved safety profiles, potentially streamlining approval.

Which Market Segments Will Drive Growth?

• Hypertension: Addressing resistant hypertension is a primary target, projected to grow at a CAGR of approximately 4% through 2030 [2].

• Heart Failure with Reduced Ejection Fraction (HFrEF): Data suggest that MRAs reduce mortality and hospitalization, positioning Finereneone as a competitor in this lucrative segment.

• Secondary indications: Conditions like primary hyperaldosteronism, edema, and possibly chronic kidney disease (CKD) may expand its eligible patient base.

What Is the Competitive Landscape?

Competitors	Market Share	Differentiators	Limitations
Spironolactone	~60% (worldwide)	Low cost, well-established	Endocrine side effects, hyperkalemia
Eplerenone	~25%	Selectivity, fewer endocrine effects	Higher cost, limited efficacy in resistant cases
Finerenone (approved in some regions)	Emerging	Superior safety profile, efficacy	Patent, market penetration still developing

Note: Finereneone must establish clear differentiation from both generic and branded competitors to gain market share.

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Regulatory Pathway and Market Entry

What Are the Anticipated Regulatory Milestones?

• Phase 2/3 clinical data release: Expected between 2024-2025.

• Submission of New Drug Application (NDA): Targeted for late 2025, following positive trial outcomes.

• Regulatory agencies considerations: FDA’s priority review pathways and EMA’s adaptive licensing could accelerate approval timelines for innovative therapies with significant unmet needs.

How Will Pricing and Reimbursement Impact Adoption?

• Cost considerations: Finereneone’s manufacturing costs need to be optimized for competitive pricing.

• Insurance reimbursement policies: Will depend on demonstrated safety, efficacy, and cost-effectiveness relative to existing therapies, especially in the U.S. and EU markets.

• Market access strategies: Key for broad uptake; collaborations with payers and healthcare providers are essential.

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Financial Trajectory Analysis: Revenue Projections & Key Factors

Revenue Projections (2025-2030)

Year	Estimated Global Sales (USD billion)	Assumptions
2025	N/A	Still in approval process; adoption uncertain
2026	0.2	Initial launch, early adoption in select regions
2027	0.6	Expansion post-approval, increased prescribing
2028	1.2	Broader indications, primary care integration
2029	1.8	Market penetration in developed markets
2030	2.5	Emerging markets entry, combination therapies

Sources: Industry reports, analogous drug launches, and market adoption models.

Key Drivers Influencing Revenue

• Disease epidemiology: Growth in target patient populations drives volume.

• Pricing strategies: Premium pricing justified by safety and efficacy advantages.

• Market penetration speed: Influenced by regulatory approval timing and clinical acceptance.

• Competitive actions: Patent protections and marketing strategies will influence composition and market share within core indications.

Cost Considerations & Investment Requirements

Investment Area	Estimated Cost (USD millions)	Purpose
R&D	100–150	Clinical trials, manufacturing scale-up
Regulatory	20–50	SDAs, submissions, approvals
Marketing	50–100	Market education, launch campaigns
Post-Marketing Surveillance	10–25	Safety monitoring

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Key Challenges and Risks

Challenge	Impact	Mitigation Strategies
Clinical trial risks	Delays or failures could postpone launch	Robust trial design, adaptive protocols
Regulatory hurdles	Extended review periods	Early engagement with regulators
Market competition	Market share erosion	Differentiation, strategic alliances
Patent expirations	Increased competition	Patent extensions, lifecycle management

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Comparison with Existing MRA Drugs

Attribute	Spironolactone	Eplerenone	Finerenone	Finereneone (Projected)
Approval Year	1960s	2002	2019	2025-2026 (Projected)
Indications	Hypertension, edema, HFrEF	Heart failure, hypertension	Chronic kidney disease, heart failure	Similar to finerenone, with added safety benefits
Side effect profile	Endocrine, hyperkalemia	Fewer endocrine effects	Better safety in CKD	Expected to outperform in safety

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How Will Market Dynamics Evolve?

Trends Shaping Future Growth

• Personalized medicine approaches will define patient selection, improving outcomes and safety profiles.

• Combination therapies with other cardiovascular drugs could open new therapeutic niches.

• Digital health integration may optimize dosing and adherence.

Forecasting the Long-Term Outlook

Given the rising burden of hypertension and heart failure, coupled with increasing emphasis on safety, Finereneone’s market share could grow substantially, contingent upon successful clinical and regulatory milestones. Its adoption could mirror or surpass that of finerenone in the coming decade, provided it demonstrates clear advantages over existing treatments.

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Key Takeaways

• Finereneone targets high-growth segments in cardiovascular therapy, promising better safety and efficacy than current MRAs.

• Market entry depends on successful clinical trials, regulatory approval, and strategic commercialization, with potential launch around 2025-2026.

• Revenue trajectory projects significant growth, reaching approximately USD 2.5 billion globally by 2030 under optimistic assumptions.

• Competitive positioning will depend on innovation differentiation, pricing, and market access strategies.

• Managing regulatory, clinical, and market risks through early engagement and robust planning is critical to realize its commercial potential.

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FAQs

1. What are the primary advantages of Finereneone over current MRAs?
Finereneone is expected to offer enhanced selectivity for mineralocorticoid receptors, reducing side effects like hyperkalemia and endocrine disturbances, thus improving patient safety and tolerability.

2. When is Finereneone expected to launch commercially?
Based on current development timelines, a commercial launch is anticipated between 2025 and 2026, following regulatory submissions and approval.

3. Which markets could see early adoption of Finereneone?
The United States and European Union will likely be early adopters, with subsequent expansion into Asia, Latin America, and other regions once commercialization is established.

4. How might Finereneone's pricing compare to existing drugs?
While initial pricing may be premium due to novel safety features, strategic competition and patent protections will influence long-term pricing and reimbursement strategies.

5. What are the main risks associated with Finereneone’s market success?
Risks include clinical trial failure, regulatory delays, competitive responses from well-established drugs, and market acceptance issues related to safety, efficacy, or pricing.

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References

[1] World Health Organization. Hypertension factsheet. 2021.
[2] Grand View Research. Hypertension Drugs Market Size & Trends Report. 2022.