TheraRadar
Data updated: May 26, 2026

BREXAFEMME (ibrexafungerp citrate)

First-in-Class Priority Review Fast Track
Infectious Disease Approved 2021-06-01
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
4
Years on Market

Details

Status
Prescription
First Approved
2021-06-01
Patent Cliff
2039

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

GSK
Active Ingredient: IBREXAFUNGERP CITRATE

BREXAFEMME Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2025 · 1 indication expansions
Nov 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2022 SUPPL Priority
Efficacy
FDA Letter Label
Jun 2022 SUPPL
Label · Labeling
FDA Letter Label

What BREXAFEMME Treats

2 FDA approvals

Originally approved for its first indication in 2021 . Covers 2 distinct patient populations.

  • Other (2)
🔬

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.

BREXAFEMME FDA Label Details

View full patent landscape →
5 OB patents · 3 families · 81 international docs across 27 countries

BREXAFEMME Patents & Exclusivity

Latest Patent: Jun 2039
Exclusivity: Jun 2031

Patents (5 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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Deep insights for BREXAFEMME

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2039
  • • 6 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: NDA214900 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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