TheraRadar
Data updated: May 26, 2026

DROSPIRENONE

Women's Health Approved 2022-06-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Discontinued
First Approved
2022-06-29
Patent Cliff
2031

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, CHEWABLE, TABLET

Companies

EXELTIS USA INC Lupin
Active Ingredient: DROSPIRENONE

DROSPIRENONE Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2022
Dec 2022 SUPPL
Label · Labeling
FDA Letter
Jun 2022 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What DROSPIRENONE Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
📋

Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT07340190 CDAK539A12102 2025-521000-22-00 Ph 1 not yet recruiting A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
NCT06345560 077766 Ph 1, Ph 2 recruiting Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study
NCT07293728 STUDY00028768 Ph 4 not yet recruiting A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
NCT05461573 CF113-303 Ph 3 completed Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females
NCT05706753 CR109284 2022-002828-12, 70033093THR1009 Ph 1 completed A Study of Milvexian in Healthy Adult Females
NCT06039826 18533 J1I-MC-GZBV Ph 1 completed A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DROSPIRENONE FDA Label Details

View full patent landscape →
15 OB patents · 4 families · 97 international docs across 26 countries

DROSPIRENONE Patents & Exclusivity

Latest Patent: Jun 2031

Patents (15 active)

US10603281 Expires Jun 28, 2031
US10849857 Expires Jun 28, 2031
US12090231 Expires Jun 28, 2031
US9603860 Expires Jun 28, 2031
US10179140 Expires Jun 28, 2031
US11413249 Expires Jun 28, 2031
US11951213 Expires Jun 28, 2031
US11351122 Expires Jun 28, 2031
US11123299 Expires Jun 28, 2031
US11439598 Expires Jun 28, 2031
US11291633 Expires Jun 28, 2031
US10987364 Expires Jun 28, 2031
US11291632 Expires Jun 28, 2031
US11504334 Expires Jun 28, 2031
US11478487 Expires Jun 28, 2031
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 15 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA216285 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.