TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

MILPROSA

PROGESTERONE
Approved 2020-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-04-29
Routes
VAGINAL
Dosage Forms
SYSTEM

Companies

FERRING PHARMS INC
Active Ingredient: PROGESTERONE

MILPROSA Approval History

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What MILPROSA Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

MILPROSA FDA Label Details

Pro

MILPROSA Patents & Exclusivity

Latest Patent: Jan 2030

Patents (3 active)

US8580293 Expires Jan 21, 2030
US10548904 Expires Feb 3, 2029
US10537584 Expires Feb 3, 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA201110 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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