Prescription medicine
Gepotidacin Brand names: Blujepa
Gepotidacin (Blujepa) is a prescription medicine with an FDA approval on record since 2025. No generic is listed; pharmacies paid $91.40 per Blujepa 750 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the gepotidacin FDA label on DailyMed (effective February 10, 2026, GlaxoSmithKline LLC); the NDA 218230 record on Drugs@FDA; every gepotidacin label on DailyMed.
Highlights of the record
FDA label of February 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBLUJEPA 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).
Forms and strengths
- 750 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 25, 2025 Blujepa, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 13, 2042 Blujepa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $91.40 per tablet Blujepa 750 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 22 through July 30, 2026
What is gepotidacin used for?
From the label: indications and usageBLUJEPA 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). ( 1.1 )
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. […]
Conditions named in the indications of gepotidacin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor.
Source: FDA drug label (Blujepa), GlaxoSmithKline LLC, effective February 10, 2026 (SPL set 80b57cfe-7819-4d95-a57d-014af42f118d), via openFDA; the full label on DailyMed
What does the patient leaflet for gepotidacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BLUJEPA?BLUJEPA, an antibiotic, can cause serious side effects, including: • changes in electrical activity of your heart called QTc prolongation. BLUJEPA can cause QTc prolongation (also called prolonged QTc interval) that can lead to serious heart rhythm problems, including Torsade de Pointes. There may be changes in your heartbeat (a fast or irregular heartbeat). Before starting BLUJEPA, tell your healthcare provider if you: o or anyone in your family has ever had a heart rhythm problem (problem with heart rate or heartbeat) or QTc prolongation. o are taking any medicines to treat heart rhythm problems. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider. o are taking medicines called moderate or strong CYP3A4 inhibitors. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider. Tell your healthcare provider right away if you have any of the following symptoms: ○fast, pounding, or uneven heartbeat ○feeling dizzy ○you lose consciousness (pass out) ○feeling lightheaded ○feeling faint • an increase of a certain chemical in your nervous system (cholinergic effects). BLUJEPA can cause an increase of a certain chemical in your nervous system, which may cause the following symptoms: ○diarrhea ○vomiting ○fainting ○trouble saying words clearly ○muscle spasms ○nausea ○more saliva in the mouth ○more sweating ○stomach pain Call your healthcare provider right away if you have trouble saying words clearly, have shortness of breath, or if you faint. These symptoms may be cholinergic effects of BLUJEPA. The increased chemical in your nervous system can also be connected to other symptoms. […]
From the patient leaflet: How should I store BLUJEPA?Store BLUJEPA tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep BLUJEPA and all medicines out of the reach of children.
Source: FDA drug label (Blujepa), GlaxoSmithKline LLC, effective February 10, 2026 (SPL set 80b57cfe-7819-4d95-a57d-014af42f118d), via openFDA; the full label on DailyMed
Is there a generic for gepotidacin (Blujepa)?
No generic gepotidacin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Blujepa tablets: the compound patent runs to December 13, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for gepotidacin (Blujepa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $91.40 per Blujepa 750 mg tablet. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Blujepa 750 mg tablet | Brand | $91.40 per tablet | $2,742.06 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the gepotidacin label say about other medicines?
The gepotidacin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA. |
| Succinylcholine | drug interactions | As gepotidacin is an acetylcholinesterase inhibitor, there is potential for an exaggerated effect of concomitantly administered succinylcholine‑type neuromuscular blocking agents resulting in a delay in recovery of neuromuscular function. |
Source: FDA drug label (Blujepa), GlaxoSmithKline LLC, effective February 10, 2026 (SPL set 80b57cfe-7819-4d95-a57d-014af42f118d), via openFDA; the full label on DailyMed
What do FAERS reports show for gepotidacin?
The FDA Adverse Event Reporting System holds 22 reports that list gepotidacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as gepotidacin?
9 other medicines are given the same way (oral) and in the same FDA class as gepotidacin or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxycycline | Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin and clavulanate | Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Nitrofurantoin | Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Minocycline | Urinary tract infections | 21 labelers | $0.343 per capsule 100 mg capsule | No current entry |
| Methenamine | Urinary tract infections | 10 labelers | $0.313 per tablet 1 g tablet | No current entry |
| Fosfomycin | Urinary tract infections | 10 labelers | $26.22 per unit 3 g sachet | No current entry |
| Sulfadiazine | Urinary tract infections | 2 labelers | $15.06 per tablet 500 mg tablet | No current entry |
| Pivmecillinam | Urinary tract infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as gepotidacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to gepotidacin
- 9 medicines for the same use
- Gepotidacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other