Data updated: Mar 10, 2026
DROSPIRENONE
DROSPIRENONE
Approved 2022-06-29
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET, CHEWABLE, TABLET
DROSPIRENONE Approval History
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What DROSPIRENONE Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
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
ProDROSPIRENONE 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
+ 5 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.