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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Inspra (2023)

Total Spending

$369K

Total Claims

275

Beneficiaries

Avg Cost/Unit

$13.57

Spending Trend

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

YoY Change:+8.8%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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