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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Carospir (2023)

Total Spending

$568K

Total Claims

719

Beneficiaries

238

Avg Cost/Unit

$3.68

Spending Trend

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

YoY Change:+4.8%

5yr CAGR:+10.2%

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

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	—	—