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AUGMENTIN '125'

NDA

AMOXICILLIN; CLAVULANATE POTASSIUM | N050597 | US ANTIBIOTICS LLC

2 strengths0 unique patents0 unique exclusivities

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Aurobindo Pharmaceuticals Limited (EAS Consulting Group) - Citizen Petition FDA-2010-P-0177 · 5 docket documents Aurobindo Pharmaceuticals Limited, through EAS Consulting Group, filed this citizen petition on March 26, 2010, requesting that the FDA determine whether Augmentin ES-600 (amoxicillin; clavulanate potassium) 600/5mL, NDA 50-755, manufactured by SmithKline Beecham was withdrawn from sale for reasons	505(q)	2010-03-31	Denied	—
Aurobindo Pharmaceuticals, Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2010-P-0172 · 6 docket documents Aurobindo Pharmaceuticals Limited, represented by EAS Consulting Group LLC, filed this petition on March 23, 2010 requesting that the FDA determine whether GlaxoSmithKline's Augmentin (amoxicillin; clavulanate potassium) oral suspension 200mg/5mL and 400mg/5mL, NDA 50-725, was withdrawn from sale fo	505(q)	2010-03-29	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

76 trials from ClinicalTrials.gov — 1 recruiting, 50 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization NCT00797108	Phase 2	Completed	Pfizer	35	2009-01 → 2009-06
Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia NCT02258763	Phase 4	Completed	University of Malaya	19	2014-11 → 2018-10
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children NCT02891915	Phase 4	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	385	2016-12-02 → 2019-12-16
Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain NCT03033147	N/A	Completed	Cairo University	72	2019-10-18 → 2020-03-15
Antibiotic Therapy in Erupted Tooth Extractions NCT04082598	Phase 4	Completed	Antonio Barone	165	2016-10-01 → 2019-01-30
Reduction of Intravenous Antibiotics In Neonates NCT03247920	Phase 4	Completed	Franciscus Gasthuis	510	2017-11-04 → 2021-07-15
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis NCT00335309	N/A	Completed	Ohad Ronen	50	2005-10 → 2013-08
Guidelines for Acute Sinusitis NCT00132275	N/A	Completed	University of Pittsburgh	240	2003-11 → 2006-08
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months NCT03818815	Phase 2	Completed	Novus Therapeutics, Inc	103	2019-02-21 → 2020-03-26

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
May 2, 2024	SUPPL -52	View Letter (PDF)
Aug 26, 2022	SUPPL -51	View Letter (PDF)
Jan 24, 2013	SUPPL -49	View Letter (PDF)
Jan 24, 2013	SUPPL -47	View Letter (PDF)
Oct 4, 2011	SUPPL -46	View Letter (PDF)
Dec 11, 2008	SUPPL -44	View Letter (PDF)
Apr 2, 2008	SUPPL -45	View Letter (PDF)
Aug 12, 2004	SUPPL -43	View Letter (PDF)
Jun 7, 2004	SUPPL -42	View Letter (PDF)
May 27, 2004	SUPPL -30	View Letter (PDF)
Jun 8, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Jul 22, 1985

No patent or exclusivity listings for this strength.

#002 — 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Jul 22, 1985