BLUJEPA is an antibacterial medication that treats uncomplicated urinary tract infections in adult women and adolescent girls. It also helps patients with uncomplicated urogenital gonorrhea, specifically those who have few or no other treatment options available. To help prevent the development of drug-resistant bacteria, this medication is used only when an infection is proven or strongly suspected to be bacterial in nature.
How BLUJEPA Works
This medication works by inhibiting bacterial type II topoisomerase, an enzyme essential for bacterial function. By targeting this specific protein, the drug interferes with the bacteria's ability to thrive, which helps clear the infection from the body.
Details
- Status
- Prescription
- First Approved
- 2025-03-25
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
BLUJEPA Approval History
What BLUJEPA Treats
2 indicationsBLUJEPA is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Urogenital Gonorrhea
BLUJEPA Competitive Set
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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.
BLUJEPA FDA Label Details
Indications & Usage
FDA Label (PDF)BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. Usage to R...
BLUJEPA Patents & Exclusivity
Patents (4 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 5 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.