Viewing data from:

UTEBZI

NDA

TEBIPENEM PIVOXIL HYDROBROMIDE | N215960 | GLAXOSMITHKLINE LLC

1 strength2 unique patents3 unique exclusivities

Patent Timeline

2 unique patents, 3 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

10889587

Feb. 6, 2038

12226403

Dec. 15, 2037

NCE

Jun. 17, 2031

GAIN

Jun. 17, 2036

NCE*GAIN

Jun. 17, 2036

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tebipenem Trial in Children With Shigellosis NCT05121974	Phase 2	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	132	2022-08-18 → 2026-08-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 18, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 300MG BASE

RLD

2 patents3 exclusivities▴

TABLET;ORAL | Approved: Jun 17, 2026

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10889587	Feb 6, 2038	—	Yes	Yes		—
12226403	Dec 15, 2037	—	—	Yes		—

Exclusivities (3)

Code	Date	Status
GAIN	Jun 17, 2036	Active
NCE	Jun 17, 2031	Active
NCE*GAINNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Jun 17, 2036	Active

Change History (1)

Recent changes detected for this application.

ADDED10/19/2026

UTEBZI (tebipenem pivoxil hydrobromide) gained new chemical entity exclusivity expiring Jun 2036, providing five years of regulatory exclusivity from its approval date.

New: UTEBZI (TEBIPENEM PIVOXIL HYDROBROMIDE) — exclusivity NCE*GAIN exp 06/17/2036