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

40 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants NCT02885454	Phase 1	Completed	Janssen Research & Development, LLC	24	2016-08 → 2016-12
A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)NCT03111511	Phase 1	Completed	Janssen Sciences Ireland UC	18	2017-03-27 → 2017-08-23
The Effect of Oral Contraceptives on Women Balance NCT02855294	Phase 4	Completed	Cairo University	100	2015-01 → 2016-07
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study NCT02817841	Phase 3	Completed	Estetra	2,148	2016-08-30 → 2018-11-16
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam NCT03353857	Phase 1	Completed	Bayer	68	2017-11-29 → 2019-02-19
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension NCT00420342	Phase 2	Completed	Bayer	92	2007-01 → 2008-09
Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone NCT01482338	Phase 4	Completed	Chulalongkorn University	90	2011-06 → 2012-03
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers NCT02852681	Phase 1	Completed	Estetra	28	2015-08 → 2016-04
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives NCT01291004	Phase 1	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	206	2011-01-31 → 2012-03-31
Treatment Choice in Primary Dysmenorrhea NCT03124524	Phase 4	Completed	Adana Numune Training and Research Hospital	99	2015-01-15 → 2016-10-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$6.61

per ea

Lowest NADAC/Unit

$6.61

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00642747001SLYND 4 MG TABLET	$6.61	EA	Brand	—	2026-06-17
00642747002SLYND 4 MG TABLET	$6.61	EA	Brand	—	2026-06-17

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

Medicare Part D Spending

CMS annual spending data for Slynd (2024)

Total Spending

$2.0M

Total Claims

6,063

Beneficiaries

1,718

Avg Cost/Unit

$6.86

Spending Trend

$11K(2019)→$185K(2020)→$558K(2021)→$1.1M(2022)→$1.9M(2023)→$2.0M(2024)

YoY Change:-7.0%

5yr CAGR:-1.0%

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

API Supply Chain11 active DMFs2 inactive

10 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

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDROSPIRENONE

DMF 388562026

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) · 7 use codes

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	—	—