Viewing data from:

CAROSPIR

NDA

SPIRONOLACTONE | N209478 | CMP DEVELOPMENT LLC

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

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Today

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

Oct. 28, 2036

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CMP Development, LLC v. Amneal Pharmaceuticals LLC 1:2021cv00549 5 patentsANDA 215572spironolactone	D. Del.	2021-04-16	Terminated 2023-10-11	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

168 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 106 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation NCT03929718	Early Phase 1	Active	Piedmont Healthcare	50	2019-04-24 → 2027-09
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
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction NCT02901184	Phase 3	Recruiting	Uppsala University	2,000	2017-11-23 → 2026-12
Hyperandrogenemia and Altered Day-night LH Pulse Patterns NCT03068910	Early Phase 1	Recruiting	University of Virginia	32	2016-07-21 → 2025-12-01
Spironolactone for Pulmonary Arterial Hypertension NCT01712620	Phase 2	Recruiting	National Institutes of Health Clinical Center (CC)	70	2014-01-10 → 2026-12-31
Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD NCT03593317	Phase 2	Recruiting	Hospices Civils de Lyon	120	2024-12-20 → 2029-12
Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy NCT00879060	Phase 4	Completed	Tufts Medical Center	53	2007-11 → 2012-11
The Effect of Amiloride and Spironolactone in Patients With Hypertension NCT01388088	Phase 4	Completed	Erling Bjerregaard Pedersen	23	2010-09 → 2012-02
Curing Atrial Fibrillation in Heart Failure NCT00292162	N/A	Completed	NHS Greater Glasgow and Clyde	41	2007-01 → 2009-07
Exploring Mechanisms and Morphology of QT Interval Prolongation NCT03291145	N/A	Completed	Herlev and Gentofte Hospital	28	2017-06-27 → 2019-01-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$3.45

per ml

Lowest NADAC/Unit

$1.55

per ml

Brand NDCs

Generic NDCs

Avg Brand: $3.45

Avg Generic: $1.66

52% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
46287002004CAROSPIR 25 MG/5 ML SUSPENSION	$3.45	ML	Brand	$1.55	2026-06-17
00574113316SPIRONOLACTONE 25 MG/5 ML SUSP	$1.77	ML	Generic	—	2026-06-17
00574113304SPIRONOLACTONE 25 MG/5 ML SUSP	$1.55	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (5 FSS, 3 Big4)

Lowest Price

$64.45

Highest Price

$1193.03

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
46287-0020-01CAROSPIR 5MG/ML SUSP,ORAL	$1193.03	FSS	CMP Pharma	07/14/2026
46287-0020-01CAROSPIR 5MG/ML SUSP,ORAL	$1193.03	Big4	CMP Pharma	07/14/2026
46287-0020-04CAROSPIR 5MG/ML SUSP,ORAL	$324.28	FSS	CMP Pharma	07/14/2026
46287-0020-04CAROSPIR 5MG/ML SUSP,ORAL	$308.61	Big4	CMP Pharma	07/14/2026
00574-1133-04SPIRONOLACTONE 5MG/ML SUSP,ORAL	$64.45	FSS	Padagis Sourcing Solutions LLC	09/30/2026
00574-1133-16SPIRONOLACTONE 5MG/ML SUSP,ORAL	$340.24	FSS	Padagis Sourcing Solutions LLC	09/30/2026
46287-0020-50CAROSPIR 5MG/ML SUSP,ORAL	$225.13	FSS	CMP Pharma	07/14/2026
46287-0020-50CAROSPIR 5MG/ML SUSP,ORAL	$172.41	Big4	CMP Pharma	07/14/2026

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

Medicare Part D Spending

CMS annual spending data for Carospir (2024)

Total Spending

$186K

Total Claims

291

Beneficiaries

Avg Cost/Unit

$3.35

Spending Trend

$119K(2019)→$235K(2020)→$355K(2021)→$475K(2022)→$568K(2023)→$186K(2024)

YoY Change:-8.8%

5yr CAGR:+5.4%

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

API Supply Chain9 active DMFs9 inactive

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

GEDEON RICHTER PLCSPIRONOLACTONE USP

DMF 140771999

EUROAPI FRANCESPIRONOLACTONE

DMF 172642004

TIANJIN TIANYAO PHARMACEUTICALS CO LTDSPIRONOLACTONE USP BULK

DMF 182382005

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 202862007

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDSPIRONOLACTONE

DMF 268812013

TIANJIN JINJIN PHARMACEUTICAL CO LTDSPIRONOLACTONE USP BULK API

DMF 301922015

HUBEI GOTO BIOTECHNOLOGY CO LTDSPIRONOLACTONE

DMF 323702018

DASAMI LAB PRIVATE LTDSPIRONOLACTONE USP

DMF 366782022

NORTEC QUIMICA SASPIRONOLACTONE

DMF 377082024

ANTIBIOTICOS SPAInactiveSPIRONOLACTONE

DMF 26571976

DIPHARMA FRANCIS SRLInactiveSPIRONOLACTONE

DMF 30521977

SCHERING AGInactiveSPIRONOLACTONE

DMF 33321978

MEDIMPEX NORTHAMERICA INCInactiveSPIRONOLACTONE USP XIX

DMF 33431978

BOEHRINGER MANNHEIM GMBHInactiveSPIRONOLACTONE (BULK FORM) USP XIX, BP 1973

DMF 33501978

DIOSYNTH BVInactiveSPIRONOLACTONE MICRO

DMF 37181980

OLON SPAInactiveSPIRONOLACTONE

DMF 185462005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveSPIRONOLACTONE

DMF 198592006

PIRAMAL HEALTHCARE UK LTDInactiveSPIRONOLACTONE USP

DMF 254962012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 25, 2023	SUPPL -6	View Letter (PDF)
Sep 8, 2021	SUPPL -2	View Letter (PDF)
Jun 29, 2021	SUPPL -3	View Letter (PDF)
Aug 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/5ML

RLDAB

8 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Aug 4, 2017

Patents (8) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9757394	Oct 28, 2036	—	—	Yes		—
10493083	Oct 28, 2036	—	—	Yes	—	—
10624906	Oct 28, 2036	—	—	Yes	—	—
10660907	Oct 28, 2036	—	—	Yes	—	—
10888570	Oct 28, 2036	—	—	Yes	—	—
11389461	Oct 28, 2036	—	—	Yes	—	—
11395828	Oct 28, 2036	—	—	—		—
11491166	Oct 28, 2036	—	—	Yes	—	—