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.

This drug has ninety-three patent family members in forty-seven 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 will be eligible for patent challenges on July 9, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for KERENDIA

International Patents:	93
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	5
Patent Applications:	104
Drug Prices:	Drug price information 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
Bayer	Phase 2

See all KERENDIA clinical trials

Pharmacology for KERENDIA

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

US Patents and Regulatory Information for KERENDIA

KERENDIA is protected by two US patents and two 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
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
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	RE49826			Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes	8,436,180		Y	Y

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/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 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

Malaysia

Mexico

Morocco

Netherlands

New Zealand

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
South Africa	200905730	Substituted 4-Aryl-1,4-Dihydro-1,6-Naphthyridinamides and use thereof
Tunisia	2009000318	SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF
Russian Federation	2743429	СПОСОБ ПОЛУЧЕНИЯ (4S)-4-(4-ЦИАНО-2-МЕТОКСИФЕНИЛ)-5-ЭТОКСИ-2,8-ДИМЕТИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИН-3-КАРБОКСАМИДА И ЕГО ОЧИСТКА ДЛЯ ПРИМЕНЕНИЯ В КАЧЕСТВЕ ФАРМАЦЕВТИЧЕСКОГО БИОЛОГИЧЕСКИ АКТИВНОГО ВЕЩЕСТВА (METHOD OF PRODUCING (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5-ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE-3-CARBOXAMIDE AND PURIFICATION THEREOF FOR USE AS PHARMACEUTICAL BIOLOGICALLY ACTIVE SUBSTANCE)
Costa Rica	10976	4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Hong Kong	1251565	用於製備(4S)-4-(4-氰基-2-甲氧基苯基)-5-乙氧基-2，8-二甲基-1，4-二氫-1，6-萘啶-3-甲酰胺的方法及其用於用作藥物活性物質的純化 (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)
Netherlands	301192
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

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	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
2132206	122022000030	Germany		PRODUCT NAME: FINERENON, SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	2290018-7	Sweden		PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. 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
2132206	C02132206/01	Switzerland		PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021

Market Dynamics and Financial Trajectory for Kerendia

Introduction

Kerendia, developed by Bayer, is a groundbreaking non-steroidal mineralocorticoid receptor antagonist (nsMRA) approved for the treatment of chronic kidney disease (CKD) in patients with Type 2 diabetes. This article delves into the market dynamics and financial trajectory of Kerendia, highlighting its performance, competitive landscape, and future prospects.

Approval and Clinical Significance

Kerendia was approved by the FDA in July 2021, marking a significant milestone in the treatment of CKD and associated cardiovascular risks. The drug is designed to block the production of steroids that degrade heart function and lead to kidney damage through fibrosis and inflammation[1].

Market Positioning

Kerendia enters a market dominated by SGLT2 inhibitors such as AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana. Despite being developed before these competitors, Kerendia's approval came later, giving it a challenging entry into a well-established market. However, its unique mechanism of action as an nsMRA sets it apart from existing treatments[1].

Competitive Landscape

The CKD and diabetic kidney disease market is highly competitive, with Farxiga being a major player. Farxiga generated $1.96 billion in sales in 2020, a 30% increase from the previous year. Invokana also holds a significant share, with $795 million in sales in 2020. Kerendia, while showing promising results, faces stiff competition, with estimated peak sales of $533 million by 2026[1].

Clinical Trials and Outcomes

Kerendia's clinical trials have demonstrated its efficacy in reducing the composite risk of cardiovascular death, nonfatal heart attack, stroke, or hospitalization for heart failure. The FIGARO-DKD trial further reinforced its cardiovascular benefits, positioning Kerendia as a valuable treatment option for patients at high risk of cardiovascular outcomes[1].

Financial Performance

In the second quarter of 2024, Kerendia showed impressive sales growth, increasing by 72.9% year-over-year. This growth is part of Bayer's overall pharmaceutical division performance, which saw a 4.5% increase in sales to around $5.02 billion[5].

Quarterly and Annual Projections

Bayer's pharmaceuticals business, driven by Kerendia and other new products like Nubeqa, is expected to grow between 0% and 3% for the full year 2024. This growth is anticipated despite the increasing pressure from generics on Bayer's blockbuster drug Xarelto. Kerendia's strong performance is a key factor in compensating for these losses[2].

Revenue Contribution

Kerendia, along with Nubeqa, is one of the main drivers of Bayer's pharmaceutical sales growth. The company's guidance indicates that these launch products are crucial for maintaining and increasing sales, even as older products face generic competition[2].

Strategic Importance

Kerendia is vital for Bayer's strategy to mitigate the impact of patent cliffs for its best-selling drugs, such as Xarelto and Eylea. The drug's success is part of Bayer's broader effort to launch new blockbusters and maintain its market position in the pharmaceutical sector[1].

Competitive Challenges and Future Prospects

Novo Nordisk's acquisition of KBP Biosciences' phase 3 challenger, ocedurenone, poses a potential threat to Kerendia. Ocedurenone is being evaluated for its effect on systolic blood pressure and could carve out a niche in treating uncontrolled hypertension in patients with advanced CKD. However, Kerendia's established market presence and ongoing clinical development, including its expansion into heart failure treatment, position it strongly for continued growth[4].

Market Expansion and Clinical Development

Bayer has expanded Kerendia's clinical development program to include heart failure, with the drug recently acing a Phase III study in this indication. This expansion significantly enhances Kerendia's market potential by addressing a broader range of cardiovascular and kidney diseases[5].

Financial Impact on Bayer

The success of Kerendia contributes to Bayer's overall financial health. Despite challenges in the agricultural market and lower earnings in some divisions, Bayer's pharmaceutical business remains a strong performer. The company's free cash flow improved significantly in Q2 2024, partly due to the strong performance of its new pharmaceutical products, including Kerendia[2].

Conclusion

Kerendia has made a significant impact in the market for chronic kidney disease and cardiovascular treatments since its approval in 2021. Despite entering a competitive market, Kerendia's unique mechanism and strong clinical outcomes have positioned it for substantial growth. As Bayer continues to navigate the challenges of patent cliffs and market competition, Kerendia remains a critical component of its pharmaceutical portfolio.

Key Takeaways

• Approval and Mechanism: Kerendia is the first non-steroidal mineralocorticoid receptor antagonist approved for CKD and heart disease.
• Market Position: Kerendia competes with established SGLT2 inhibitors like Farxiga and Invokana.
• Financial Performance: Kerendia has shown significant sales growth, contributing to Bayer's pharmaceutical division's overall performance.
• Strategic Importance: Kerendia is crucial for Bayer's strategy to mitigate patent cliffs and launch new blockbusters.
• Competitive Challenges: Novo Nordisk's acquisition of ocedurenone poses a potential competitive threat.
• Market Expansion: Kerendia's clinical development has expanded to include heart failure treatment.

FAQs

Q1: What is Kerendia, and how does it work? Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that blocks the production of steroids in the body, thereby reducing kidney damage and heart function degradation caused by fibrosis and inflammation.

Q2: When was Kerendia approved, and what is its primary indication? Kerendia was approved by the FDA in July 2021 for the treatment of chronic kidney disease (CKD) in patients with Type 2 diabetes.

Q3: How does Kerendia compare to other treatments like Farxiga and Invokana? Kerendia competes with SGLT2 inhibitors like Farxiga and Invokana but has a unique mechanism of action as an nsMRA. While it faces stiff competition, Kerendia's clinical trials have demonstrated its efficacy in reducing cardiovascular and kidney risks.

Q4: What are the financial projections for Kerendia? Kerendia is expected to contribute significantly to Bayer's pharmaceutical sales growth, with estimated peak sales of $533 million by 2026. It has already shown a 72.9% year-over-year sales increase in Q2 2024.

Q5: What are the potential competitive threats to Kerendia? Novo Nordisk's acquisition of KBP Biosciences' ocedurenone, a phase 3 challenger to Kerendia, poses a potential competitive threat. Ocedurenone is being evaluated for its effect on systolic blood pressure and could carve out a niche in treating uncontrolled hypertension in patients with advanced CKD.

Sources

1. FiercePharma: Bayer's Farxiga rival Kerendia scores long-awaited kidney and heart nod[1].
2. Bayer: Bayer Q2 Media Update[2].
3. Bayer: Modest performance in challenging agricultural market environment – Group outlook confirmed[3].
4. FierceBiotech: Novo Nordisk buys rival to Bayer's Kerendia in $1.3B deal[4].
5. BioSpace: Bayer Touts 'Modest' Q2 Performance Amid Sweeping Reorganization[5].