Data updated: Mar 10, 2026
BREXAFEMME
IBREXAFUNGERP CITRATE
Approved 2021-06-01
2
Indications
--
Phase 3 Trials
2
Priority Reviews
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-06-01
- Routes
- ORAL
- Dosage Forms
- TABLET
BREXAFEMME Approval History
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What BREXAFEMME Treats
2 FDA approvalsOriginally approved for its first indication in 2021 . Covers 2 distinct patient populations.
- Other (2)
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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.
BREXAFEMME FDA Label Details
ProBREXAFEMME Patents & Exclusivity
Latest Patent: Jun 2039
Exclusivity: May 2031
Patents (6 active)
US11534433
Expires Jun 10, 2039
US10370406
Expires Jan 19, 2035
US10927142
Expires Jan 19, 2035
US10174074
Expires Jan 19, 2035
US8188085
Expires Aug 28, 2030
Exclusivity
NCE
Until Jun 2026
GAIN
Until Jun 2031
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.