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NCE-1 Intelligence & Market Opportunity

Utebzi

Tebipenem pivoxil
Carbapenem Antibacterial
Oral Tablet

Utebzi is an FDA approved oral antibacterial indicated for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults with limited or no alternative oral treatment options. As the first and only FDA-approved oral carbapenem, it represents a significant advancement in the management of serious bacterial infections while supporting outpatient treatment strategies. For clinical trial and first-to-file teams, monitoring Utebzi’s market adoption, exclusivity timeline, and availability will be important, as it may emerge as a relevant comparator in infectious disease and antibacterial drug development studies.

Approval Date
17-Jun-26
NCE-1 Date
17-Jun-30
NCE Date
17-Jun-31
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
17
2027
52
2028
115
2029
215
2030
272
2031
339
2032
405
Molecule profile

Details & specifications

Molecule
Tebipenem pivoxil
Innovator
GLAXOSMITHKLINE
Dosage Form
Oral Tablet
Strength
EQ 300 mg base
Therapeutic Category
Carbapenem Antibacterial
Usage
To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options
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Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
Exclusivity windows framed around the decisions generics teams actually make.
Partnership on demand
From API sourcing to dossier support — one request starts the conversation.

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