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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

UTEBZI

NDANot in Orange Book

TEBIPENEM PIVOXIL HYDROBROMIDE | N215960 | GLAXOSMITHKLINE

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

No clinical trials found on ClinicalTrials.gov for this drug

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

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TABLET;ORAL | Approved: Jun. 17, 2026

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10889587Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Feb 6, 2038	—	Yes	Yes		—
12226403Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Dec 15, 2037	—	—	Yes		—