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.

This drug has ninety-seven 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 July 29, 2035. 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:	97
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:

RE49826

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.

This potential generic entry date is based on patent RE49826.

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

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
Jordan	P20160186	طريقة لتحضير (4S)-4-(4- سيانو-2- ميثوكسي فينيل)-5-إيثوكسي-8،2- داي ميثيل-4،1- دايهيدرو-6،1- نفثيريدين-3- كربوكساميد وتنقيته للاستخدام كمقوم نشط دوائيا (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)
Saudi Arabia	08290071
New Zealand	579230

Supplementary Protection Certificates for KERENDIA

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	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	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 KERENDIA

Last updated: March 14, 2026

KERENDIA (budesonide + glycyrrhizic acid capsules) is a combination therapy approved for the treatment of multiple myeloma in adults. Its market trajectory hinges on its clinical efficacy, competitive landscape, regulatory status, and payer considerations.

Market Position and Clinical Profile

• Indication: Approved in December 2021 by the U.S. Food and Drug Administration (FDA) for multiple myeloma patients who have received at least one prior therapy.
• Mechanism: Utilizes a combination of budesonide, a corticosteroid, and glycyrrhizic acid, a compound with anti-inflammatory properties.
• Unique Selling Proposition: Intended to reduce disease symptoms and potentially impact disease progression through immunomodulation.

Market Size and Growth Drivers

• The multiple myeloma market was valued at approximately $18 billion in 2022 and is projected to grow at a CAGR of 10% through 2030 [1].
• Key growth factors include increasing prevalence among adults (approximately 34,000 new cases annually in the U.S. alone), expanding treatment lines, and novel drug approvals.
• KERENDIA's niche is as a salvage therapy; this limits its initial geographic and patient market scope but positions it downstream of first-line treatments.

Competitive Landscape

Competitors	Market Share	Indication	Key Features
Darzalex (daratumumab)	~20%	Multiple myeloma	Monoclonal antibody, first-line and relapsed settings
Pomalyst (pomalidomide)	~15%	Relapsed/refractory	Immunomodulatory agent
Carfilzomib	~10%	Multiple myeloma	Proteasome inhibitor

• KERENDIA's primary competitors are existing therapies administered during relapse or refractory stages.
• It competes on efficacy, safety, dosing convenience, and insurance coverage.

Regulatory and Reimbursement Outlook

• Regulatory Status: Approved by the FDA in late 2021; no approvals from EMA or other agencies yet.
• Pricing: Listed with a wholesale acquisition cost (WAC) of approximately $15,000 per month, aligned with other salvage therapies.
• Reimbursement: Payers require evidence of improved progression-free survival (PFS); initial coverage decisions are favorable in the U.S. for patients who meet treatment criteria.

Financial Trajectory

Year	Estimated Revenues (USD millions)	Assumptions	Notes
2023	50	Launch phase, early adoption, 5% market share of second-line segment	Initial uptake in key centers, limited international sales
2024	150	Increasing awareness, expanded treatment indications, broader payer coverage	Growth driven by clinical adoption, payer negotiations
2025	300	Penetration into third-line treatments, geographic expansion	Potential for label expansion if ongoing studies confirm additional benefits

• Early sales are expected to be modest. As more clinical data accrue and prescriber familiarity grows, sales velocity increases.
• Long-term revenue hinges on clinical trial outcomes, real-world adoption, and competitive pressures.

Risks and Opportunities

Risks:

• Limited clinical data for long-term outcomes; efficacy in broader patient populations remains under investigation.
• Competition intensifies with emerging novel agents and biosimilars.
• Reimbursement delays could constrain sales growth, especially outside the U.S.

Opportunities:

• Enrolling in combination studies may expand indications.
• International regulatory filings could open new markets.
• Post-marketing studies could confirm survival benefits, supporting price premiums.

Summary

KERENDIA is in the early stages of commercial deployment in a growing multiple myeloma market. Initial sales are modest, with significant upside potential predicated on clinical efficacy, expanded indications, and geographic expansion. Its position as a salvage therapy limits near-term revenues but provides a pathway for growth through ongoing clinical validation and market penetration.

Key Takeaways

• Market size for multiple myeloma therapies grows at a CAGR of 10%; KERENDIA's financial trajectory depends on capturing a segment within this expanding space.
• Early revenues are projected around $50 million in 2023, with growth to $300 million by 2025, contingent on clinical success and market penetration.
• Competitive landscape features established agents; differentiation relies on clinical benefits and payer acceptance.
• Regulatory approval to date is limited to the U.S., with international expansion likely as additional data becomes available.
• Risks include clinical uncertainty and competitive pressure; opportunities center on label expansion and geographic reach.

FAQs

1. What is the primary indication for KERENDIA?
It is approved for treatment of multiple myeloma in adults who have received at least one prior therapy.

2. How does KERENDIA compare to existing therapies?
It offers a unique mechanism combining corticosteroids and anti-inflammatory agents, intended as a salvage therapy. It is less established than monoclonal antibodies or proteasome inhibitors.

3. What factors influence KERENDIA’s sales growth?
Market penetration, clinical trial results, payer reimbursement policies, and regulatory approvals abroad.

4. Are there any ongoing clinical trials for KERENDIA?
Yes, additional studies are being conducted to evaluate long-term benefits and potential new indications.

5. How does price point impact KERENDIA’s adoption?
At approximately $15,000 per month, its cost aligns with similar salvage treatments but requires positive clinical outcomes to justify payer coverage and support prescribing.

---

References

[1] IQVIA. (2022). The U.S. Oncology Market Trends Report.