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KERENDIA

NDA

FINERENONE | N215341 | BAYER HEALTHCARE PHARMACEUTICALS INC

3 strengths2 unique patents3 unique exclusivities

Patent Timeline

2 unique patents, 3 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

RE49826

Jul. 29, 2035

8436180

Aug. 26, 2033

NCE

Jul. 9, 2026

I-970

Jul. 11, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

10 cases on OB patents (9 active) from PACER

Case	Court	Filed	Status	Judge
BAYER HEALTHCARE PHARMACEUTICALS INC. et al v. DR. REDDY'S LABORATORIES, LTD. et al 1:2025cv16901 2 patentsANDA 220694finerenone	D.N.J.	2025-10-24	Terminated 2026-02-06	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Dr. Reddys Laboratories, Ltd. et al 1:2025cv01299 2 patentsANDA 220694finerenone	D. Del.	2025-10-23	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. MSN Pharmaceuticals Inc. et al 1:2025cv01281 2 patentsANDA 220821finerenone	D. Del.	2025-10-20	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Macleods Pharmaceuticals Limited et al 1:2025cv01280 2 patentsANDA 220747finerenone	D. Del.	2025-10-20	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. SABA Ilac Sanayi ve Ticaret A. S. 1:2025cv01282 2 patentsANDA 220708finerenone	D. Del.	2025-10-20	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. ScieGen Pharmaceuticals, Inc. 1:2025cv01283 2 patentsANDA 220745finerenone	D. Del.	2025-10-20	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Zydus Lifesciences Limited et al 1:2025cv01260 2 patentsANDA 220636finerenone	D. Del.	2025-10-15	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Apotex Inc. et al 1:2025cv01262 2 patentsANDA 220684finerenone	D. Del.	2025-10-15	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Teva Pharmaceuticals, Inc. et al 1:2025cv01247 2 patentsANDA 220737finerenone	D. Del.	2025-10-09	Active	—
Bayer HealthCare Pharmaceuticals Inc. et al v. Aurobindo Pharma Limited et al 1:2025cv01246 2 patentsANDA 220696finerenone	D. Del.	2025-10-09	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov — 4 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States NCT06608212	—	Active	Bayer	150,000	2024-10-09 → 2026-06-30
A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting NCT05348733	—	Active	Bayer	4,613	2022-06-13 → 2026-12-22
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction NCT07192952	Phase 3	Recruiting	Bayer	117	2026-06-01 → 2030-12-30
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria NCT05457283	Phase 3	Recruiting	Bayer	100	2022-11-08 → 2028-12-28
An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score NCT07554469	—	Recruiting	Bayer	500	2026-05-26 → 2029-04-30
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria NCT05196035	Phase 3	Recruiting	Bayer	219	2022-03-28 → 2027-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Kerendia (2023)

Total Spending

$269.7M

Total Claims

271,195

Beneficiaries

63,625

Avg Cost/Unit

$22.00

Spending Trend

$2.8M(2021)→$74.1M(2022)→$269.7M(2023)

YoY Change:+7.1%

5yr CAGR:+6.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain18 active DMFs

17 active API suppliers hold Drug Master Files for this ingredient.

LEE PHARMA LTDFINERENONE

DMF 387282025

AMI LIFESCIENCES PRIVATE LTDFINERENONE

DMF 388892023

CHANGZHOU PHARMACEUTICAL FACTORYFINERENONE

DMF 398882024

MAITHRI DRUGS PRIVATE LTDFINERENONE

DMF 402632024

AURISCO PHARMACEUTICAL CO LTDFINERENONE

DMF 404972024

ZENJI PHARMACEUTICALS (SUZHOU) LTDFINERENONE

DMF 405012024

MACLEODS PHARMACEUTICALS LTDFINERENONE

DMF 405042024

TAPI NL B.V.FINERENONE

DMF 410242025

MSN LIFE SCIENCES PRIVATE LTDFINERENONE

DMF 411502025

OPTIMUS DRUGS PRIVATE LTDFINERENONE

DMF 411542025

AMI LIFESCIENCES PRIVATE LTDFINERENONE (PROCESS-II)

DMF 412322025

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDFINERENONE

DMF 412892025

VIYASH LIFE SCIENCES PRIVATE LTDFINERENONE

DMF 413592025

DR REDDYS LABORATORIES LTDFINERENONE

DMF 414302025

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDFINERENONE

DMF 415252025

ALIVUS LIFE SCIENCES LTDFINERENONE

DMF 416032025

SICHUAN KELUN PHARMACEUTICAL CO LTDFINERENONE

DMF 423512025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDFINERENONE

DMF 426012025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2025	SUPPL -9	View Letter (PDF)
Sep 2, 2022	SUPPL -1	View Letter (PDF)
Jul 12, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

RLD

2 patents2 exclusivities▴

TABLET;ORAL | Approved: Jul 9, 2021

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE49826	Jul 29, 2035	—	Yes	—	—	—
8436180	Aug 26, 2033	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
I-970	Jul 11, 2028	Active
NCE	Jul 9, 2026	< 1 year

#002 — 20MG

RLD

2 patents2 exclusivities▾

TABLET;ORAL | Approved: Jul 9, 2021

#003 — 40MG

RLD

2 patents2 exclusivities▾

TABLET;ORAL | Approved: Jul 11, 2025

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

KERENDIA (finerenone) receives regulatory status as a Reference Standard product under NDA 215341.

Old: No

New: Yes

MODIFIEDrs7/1/2026

Finerenone (KERENDIA) lost its reference-listed drug (RLD) designation for NDA 215341, Supplement 002.

Old: Yes

New: No