Case	Court	Filed	Status	Judge
EXELTIS USA, INC. et al v. GLENMARK PHARMACEUTICALS LIMITED et al 2:2025cv17250 18 patentsANDA 219233drospirenone	D.N.J.	2025-11-06	Active	—
Exeltis USA, Inc. et al v. Lupin Ltd. et al 1:2022cv00434 6 patentsANDA 216936drospirenone	D. Del.	2022-04-01	Terminated 2025-09-29	—

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 Slynd (2023)

Total Spending

$1.9M

Total Claims

5,404

Beneficiaries

1,426

Avg Cost/Unit

$7.37

Spending Trend

$11K(2019)→$185K(2020)→$558K(2021)→$1.1M(2022)→$1.9M(2023)

YoY Change:+0.6%

5yr CAGR:+1.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs2 inactive

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

BAYER AGDROSPIRENONE

DMF 121381996

GEDEON RICHTER PLCDROSPIRENONE USP

DMF 178662004

INDUSTRIALE CHIMICA SRLDROSPIRENONE USP

DMF 206762007

STERLING SPADROSPIRENONE

DMF 217332008

NEWCHEM SPADROSPIRENONE

DMF 228022009

TAPI NL BVDROSPIRENONE

DMF 228782009

LUPIN LTDDROSPIRENONE USP

DMF 233972010

SUN PHARMACEUTICAL INDUSTRIES LTDDROSPIRENONE USP

DMF 235802010

SYMBIOTEC PHARMALAB PRIVATE LTDDROSPIRENONE USP

DMF 328852018

NEWCHEM SPADROSPIRENONE EP/USP

DMF 367092022

CRYSTAL PHARMA SAUInactiveDROSPIRENONE NON MICRONIZED AND MICRONIZED

DMF 257962012

INDUSTRIALE CHIMICA SRLInactiveDROSPIRENONE (PROCESS 2)

DMF 417642025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 24, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG

RLD

15 patents0 exclusivities▴

TABLET;ORAL | Approved: May 23, 2019

Patents (15)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9603860	Jun 28, 2031	—	—	—		—
10179140	Jun 28, 2031	—	—	—		—
10603281	Jun 28, 2031	—	—	—		—
10849857	Jun 28, 2031	—	—	Yes		—
10987364	Jun 28, 2031	—	—	Yes	—	—
11123299	Jun 28, 2031	—	—	Yes	—	—
11291632	Jun 28, 2031	—	—	Yes	—	—
11291633	Jun 28, 2031	—	—	Yes	—	—
11351122	Jun 28, 2031	—	—	Yes	—	—
11413249	Jun 28, 2031	—	—	—		—
11478487	Jun 28, 2031	—	—	Yes	—	—
11504334	Jun 28, 2031	—	—	Yes	—	—
11951213	Jun 28, 2031	—	—	—		—
12090231	Jun 28, 2031	—	—	—		—
12280151	Jun 28, 2031	—	—	Yes	—	—