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-three patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for finerenone

International Patents:	93
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	27
Patent Applications:	281
What excipients (inactive ingredients) are in finerenone?	finerenone excipients list
DailyMed Link:	finerenone at DailyMed

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

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
The George Institute	Phase 3
University Medical Center Groningen	Phase 4
Boehringer Ingelheim	Phase 4

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

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				Y
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			Y	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/005200 Kerendia 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	2014012678	SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDE AND USE THEREOF
Uruguay	30931	AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y SU USO
Slovenia	3337800
Israel	257371	שיטה להכנה של (s4)-4-(4-ציאנו-2-מתוקסיפניל)-5-אתוקסי-8,2-דימתיל-4,1-דיהידרו-6,1-נפתירידין-3-קרבוקסאמיד וטיהורו לשימוש כמרכיב רוקחי פעיל (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	301192	Netherlands		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 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	22C1017	France		PRODUCT NAME: FINERENONE ET SES SELS, SOLVATES ET SOLVATES DES SELS.; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206	2022C/538	Belgium		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217

Market Dynamics and Financial Trajectory for Finerenone

Introduction

Finerenone, marketed as Kerendia, is a non-steroidal, selective mineralocorticoid receptor antagonist that has been making significant waves in the pharmaceutical industry, particularly in the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and heart failure. Here, we delve into the market dynamics and financial trajectory of this drug.

Growing Demand for Finerenone

The demand for finerenone is driven by several key factors:

Increased Prevalence of Chronic Kidney Diseases and Type 2 Diabetes

The rising incidence of CKD and T2D has created a higher demand for effective medications like finerenone, which helps manage complications associated with these conditions[1].

Rising Awareness and Diagnosis Rates

Improved diagnostic techniques and increased awareness about kidney health have led to more patients being diagnosed with CKD, thereby increasing the demand for treatment options like finerenone[1].

Regulatory Approvals and Clinical Advancements

Successful clinical trials and regulatory approvals from health authorities such as the FDA have boosted market confidence, encouraging healthcare providers to prescribe finerenone. The FIDELIO-DKD trial, for instance, showed that finerenone reduces the risk of CKD progression and cardiovascular complications[2].

Market Segmentation and Distribution

The finerenone API market is segmented by distribution channels, including online pharmacies, offline pharmacies, and hospital pharmacies.

Online Pharmacies

Online pharmacies have gained traction due to the growing digitization of healthcare and consumer preference for convenience. They offer easy access to finerenone API, often at competitive prices, and enable a broader reach, particularly in remote areas[1].

Offline Pharmacies

Offline pharmacies represent the traditional retail model, providing personalized services and immediate access to medication. This segment remains significant due to the need for face-to-face consultations with pharmacists[1].

Hospital Pharmacies

Hospital pharmacies play a crucial role in the distribution of finerenone, especially for patients requiring immediate and specialized care.

Geographical Market Dynamics

The finerenone API market is categorized by geography to understand regional dynamics, demand, and regulatory environments.

North America

Driven by a robust healthcare infrastructure, high prevalence of CKD, and significant investments in research and development, North America is a key market for finerenone[1].

Europe

Europe is another vital market, with a strong emphasis on regulatory compliance and innovative drug formulations. This region is crucial for the growth of finerenone API[1].

Asia-Pacific

The Asia-Pacific region demonstrates rapid growth potential, fueled by increasing healthcare expenditure, rising awareness about chronic diseases, and a growing pharmaceutical manufacturing base[1].

Middle East and Africa

These regions show a slower growth trajectory due to varying healthcare access and economic challenges, but there is an emerging market for chronic disease management that finerenone can address[1].

Latin America

Latin America is seeing gradual growth in the finerenone API market as healthcare systems evolve and there is increased focus on drug availability and affordability[1].

Financial Trajectory

Cost-Effectiveness and Economic Value

The FINE-CKD model, developed to evaluate the economic value of finerenone, shows that the drug delays CKD progression and reduces cardiovascular complications, leading to significant cost savings. However, the cost-effectiveness analysis indicates that price reductions may be necessary to achieve an acceptable incremental cost-effectiveness ratio (ICER) of $50,000 per quality-adjusted life-year (QALY) gained[2][3].

Budget Impact

The potential budget impact of reimbursing finerenone is substantial, estimated to be around $148 million over three years in Canada. Price negotiations and implementation of discontinuation criteria are suggested to reduce this budget impact[3].

Market Forecast

The finerenone API market is expected to grow significantly from 2024 to 2031, driven by increasing demand and favorable market conditions. Bayer, the manufacturer, targets peak sales of over $3 billion, despite a slow start in the renal market. The recent success in the Phase III heart failure trial is expected to boost sales and achieve the projected peak[1][4].

Competitive Landscape

The market for finerenone faces competition from alternative treatment options, including other anti-hypertensive and diuretic medications. Competitive pricing and therapeutic advantages of these alternatives can restrain market growth. However, finerenone's unique cardiorenal protective properties and its performance in clinical trials position it favorably in the market[1].

Regulatory and Reimbursement Challenges

The development and approval of finerenone are subject to stringent regulatory requirements. Delays in approval processes and insufficient reimbursement coverage can limit its adoption. However, favorable reimbursement policies and supportive market access strategies in various regions can enhance the uptake of finerenone API[1].

Innovative Drug Formulations

Advancements in drug formulation that utilize finerenone API may enhance bioavailability and therapeutic effects, driving demand in the pharmaceutical market. This innovation is crucial for maintaining market competitiveness and expanding the drug's applications[1].

Investment in Research and Development

Increased investment in research and development by pharmaceutical companies to explore additional indications for finerenone can lead to broader market applications and higher overall demand. The recent Phase III trial success in heart failure is a testament to this strategy[1][4].

Healthcare Infrastructure Development

The development of healthcare infrastructure, particularly in regions with growing healthcare expenditure, supports the growth of the finerenone API market. This infrastructure development includes better diagnostic facilities and improved access to healthcare services[1].

Key Takeaways

• Growing Demand: Driven by the increasing prevalence of CKD and T2D, and improved diagnostic techniques.
• Regulatory Approvals: Successful clinical trials and regulatory approvals boost market confidence.
• Geographical Dynamics: North America, Europe, and Asia-Pacific are key markets, with varying growth trajectories in other regions.
• Cost-Effectiveness: Finerenone offers significant economic value but may require price adjustments for optimal cost-effectiveness.
• Competitive Landscape: Faces competition from alternative treatments but has unique therapeutic advantages.
• Regulatory and Reimbursement: Subject to stringent regulations and reimbursement challenges.
• Innovation and R&D: Ongoing research and development are crucial for expanding market applications.

FAQs

Q: What are the primary indications for finerenone?

A: Finerenone is primarily used in treating chronic kidney disease associated with type 2 diabetes and has shown potential in reducing cardiovascular events in heart failure patients[2][4].

Q: How does finerenone impact the progression of CKD?

A: Finerenone delays the progression of CKD and reduces the risk of cardiovascular complications, as evidenced by the FIDELIO-DKD trial[2].

Q: What are the key geographical markets for finerenone?

A: North America, Europe, and the Asia-Pacific region are the primary markets, with significant growth potential in these areas[1].

Q: What are the challenges in the reimbursement of finerenone?

A: Insufficient reimbursement coverage and high costs are significant challenges, requiring price negotiations and discontinuation criteria to manage budget impact[3].

Q: How does finerenone compare to other mineralocorticoid receptor antagonists?

A: Finerenone has shown better tolerability and reduced risk of elevated potassium levels compared to other drugs like spironolactone and eplerenone, particularly in heart failure patients[4].

Sources

1. Verified Market Research: Finerenone Api Market Size, Share, Scope, Trends And Forecast.
2. AJMC: FINE-CKD Model to Evaluate Economic Value of Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes.
3. Canada's Drug Agency: Finerenone (Kerendia) - Canada's Drug Agency.
4. Biospace: Bayer's Finerenone Hits Primary Endpoint in Phase III Heart Failure Trial.