Viewing data from:

INSPRA

NDA

EPLERENONE | N021437 | UPJOHN US 2 LLC

3 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

89 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 56 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)NCT02490904	Phase 3	Active	Central Hospital, Nancy, France	132	2016-10-19 → 2031-08
A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure NCT03984591	Phase 4	By Invitation	Bispebjerg Hospital	7,200	2020-11-01 → 2028-12-31
Early Aldo Blockade in Subclinical PA NCT07727252	Phase 2/3	Not Yet Recruiting	Xinjiang Medical University	880	2026-08-01 → 2029-08-01
Eplerenone and IOP in Healthy Adults NCT07795762	Phase 1	Not Yet Recruiting	University of Florida	30	2026-10-01 → 2027-04-01
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia NCT07238400	Phase 2	Recruiting	Massachusetts General Hospital	90	2026-03-20 → 2029-03-30
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
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure NCT01115855	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	221	2010-07 → 2015-09
A Study of LY2623091 in Male and Females With Chronic Kidney Disease NCT01427972	Phase 2	Completed	Eli Lilly and Company	42	2011-09 → 2013-03
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated NCT03165240	Phase 1	Completed	Boehringer Ingelheim	62	2017-10-05 → 2020-05-07
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes NCT03017703	N/A	Completed	University of Southern Denmark	27	2016-12-01 → 2019-12-15

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 8 NDCs

Highest NADAC/Unit

$0.4659

per ea

Lowest NADAC/Unit

$0.3052

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762172001EPLERENONE 50 MG TABLET	$0.4659	EA	Generic	—	2026-08-19
59762172002EPLERENONE 50 MG TABLET	$0.4659	EA	Generic	—	2026-08-19
59762110801EPLERENONE 50 MG TABLET	$0.4659	EA	Generic	—	2026-08-19
59762110802EPLERENONE 50 MG TABLET	$0.4659	EA	Generic	—	2026-08-19
59762110702EPLERENONE 25 MG TABLET	$0.3052	EA	Generic	—	2026-08-19
59762171003EPLERENONE 25 MG TABLET	$0.3052	EA	Generic	—	2026-08-19
59762171002EPLERENONE 25 MG TABLET	$0.3052	EA	Generic	—	2026-08-19
59762110703EPLERENONE 25 MG TABLET	$0.3052	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 20 NDCs (10 FSS, 10 Big4)

Lowest Price

$7.61

Highest Price

$250.31

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58151-0142-93INSPRA 25MG TAB	$250.31	Big4	Mylan Specialty L.P.	01/14/2027
58151-0142-93INSPRA 25MG TAB	$250.31	FSS	Mylan Specialty L.P.	01/14/2027
58151-0143-93INSPRA 50MG TAB	$250.31	Big4	Mylan Specialty L.P.	01/14/2027
58151-0143-93INSPRA 50MG TAB	$250.31	FSS	Mylan Specialty L.P.	01/14/2027
59762-1107-02EPLERENONE 25MG TAB	$13.02	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-1107-02EPLERENONE 25MG TAB	$39.40	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 20 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Inspra (2024)

Total Spending

$349K

Total Claims

253

Beneficiaries

Avg Cost/Unit

$13.28

Spending Trend

$652K(2019)→$683K(2020)→$532K(2021)→$414K(2022)→$369K(2023)→$349K(2024)

YoY Change:-2.1%

5yr CAGR:+3.9%

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

API Supply Chain6 active DMFs1 inactive

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

INDUSTRIALE CHIMICA SRLEPLERENONE

DMF 197152006

MSN LABORATORIES PRIVATE LTDEPLERENONE [ROUTE CODE: PL]

DMF 234662010

AURISCO PHARMACEUTICAL CO LTDEPLERENONE

DMF 276722013

INDUSTRIALE CHIMICA SRLEPLERENONE PH. EUR.

DMF 329982018

HETERO LABS LTDEPLERENONE

DMF 338322019

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDEPLERENONE API

DMF 370242022

APOTEX PHARMACHEM INCInactiveEPLERENONE MEK HEMISOLVATE (1:0.5)

DMF 197962006

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2025	SUPPL -18	View Letter (PDF)
May 31, 2018	SUPPL -15	View Letter (PDF)
May 5, 2016	SUPPL -13	View Letter (PDF)
May 21, 2013	SUPPL -11	View Letter (PDF)
Jul 13, 2012	SUPPL -9	View Letter (PDF)
Jun 26, 2012	SUPPL -9	View Letter (PDF)
May 9, 2008	SUPPL -6	View Letter (PDF)
Feb 4, 2008	SUPPL -5	View Letter (PDF)
Oct 7, 2003	SUPPL -2	View Letter (PDF)
Sep 27, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 27, 2002

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 27, 2002

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 27, 2002