Viewing data from:

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

7 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease NCT02545049	Phase 3	Completed	Bayer	7,352	2015-09-17 → 2021-02-02
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone NCT01807221	Phase 2	Completed	Bayer	1,066	2013-06-17 → 2014-12-09
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease NCT02540993	Phase 3	Completed	Bayer	5,734	2015-09-17 → 2020-04-14
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862 NCT01473108	Phase 1	Completed	Bayer	67	2010-03-29 → 2011-05-17
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy NCT01874431	Phase 2	Completed	Bayer	823	2013-06-12 → 2014-08-07
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers NCT02956109	Phase 1	Completed	Bayer	16	2016-11-16 → 2017-03-17
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects NCT02957396	Phase 1	Completed	Bayer	16	2016-11-17 → 2017-03-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 9 NDCs

Highest NADAC/Unit

$22.88

per ea

Lowest NADAC/Unit

$22.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50419054201KERENDIA 40 MG TABLET	$22.88	EA	Brand	—	2026-06-17
50419054202KERENDIA 40 MG TABLET	$22.88	EA	Brand	—	2026-06-17
50419054206KERENDIA 40 MG TABLET	$22.88	EA	Brand	—	2026-06-17
50419054106KERENDIA 20 MG TABLET	$22.85	EA	Brand	—	2026-06-17
50419054101KERENDIA 20 MG TABLET	$22.85	EA	Brand	—	2026-06-17
50419054102KERENDIA 20 MG TABLET	$22.85	EA	Brand	—	2026-06-17

Showing 6 of 9 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 17 NDCs (9 FSS, 8 Big4)

Lowest Price

$473.90

Highest Price

$1932.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0540-01KERENDIA 10MG TAB	$644.03	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0540-01KERENDIA 10MG TAB	$502.29	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0541-01KERENDIA 20MG TAB	$644.03	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0541-01KERENDIA 20MG TAB	$502.73	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0541-02KERENDIA 20MG TAB	$1932.20	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0541-02KERENDIA 20MG TAB	$1501.91	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026

Showing 6 of 17 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Kerendia (2024)

Total Spending

$396.3M

Total Claims

403,577

Beneficiaries

88,208

Avg Cost/Unit

$21.06

Spending Trend

$2.8M(2021)→$74.1M(2022)→$269.7M(2023)→$396.3M(2024)

YoY Change:-4.3%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain22 active DMFs

21 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

CHONGQING CARELIFE PHARMACEUTICAL CO LTDFINERENONE, NON-STERILE BULK DRUG SUBSTANCE

DMF 409062024

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

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDFINERENONE

DMF 434602026

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDFINERENONE

DMF 437352026

HEC API YICHANG CO LTDFINERENONE NON-STERILE BULK DRUG SUBSTANCE

DMF 438442026

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	Expired

#002 — 20MG

RLD

2 patents2 exclusivities▾

TABLET;ORAL | Approved: Jul 9, 2021

#003 — 40MG

RLD

2 patents2 exclusivities▾

TABLET;ORAL | Approved: Jul 11, 2025