Viewing data from:

AUGMENTIN XR

NDA

AMOXICILLIN; CLAVULANATE POTASSIUM | N050785 | US ANTIBIOTICS LLC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2024-P-2314 · 5 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Augmentin XR (amoxicillin and clavulanate potassium) extended-release tablets 1 gram/62.5 milligrams, NDA 050785, held by US Antibiotics,	505(q)	2024-05-10	Granted	Aurobindo Pharma USA, Inc.
Citizen Petition from Aurobindo Pharma USA, Inc FDA-2019-P-5237 · 5 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Sandoz Inc.'s approved generic Amoxicillin and Clavulanate Potassium Extended Release Tablets 1000 mg/62.5 mg (ANDA #090227) as an alternative ref	505(q)	2019-11-06	Open	Aurobindo Pharma USA, Inc

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$5.92

per ea

Lowest NADAC/Unit

$5.92

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
81964022028AMOX-CLAV ER 1,000-62.5 MG TAB	$5.92	EA	Generic	—	2026-06-17
81964022040AMOX-CLAV ER 1,000-62.5 MG TAB	$5.92	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Dec 26, 2024	SUPPL -19	View Letter (PDF)
May 2, 2024	SUPPL -18	View Letter (PDF)
Nov 3, 2022	SUPPL -17	View Letter (PDF)
Apr 7, 2014	SUPPL -15	View Letter (PDF)
Nov 29, 2013	SUPPL -14	View Letter (PDF)
Aug 31, 2011	SUPPL -9	View Letter (PDF)
Sep 9, 2010	SUPPL -12	View Letter (PDF)
Dec 19, 2008	SUPPL -7	View Letter (PDF)
Apr 22, 2008	SUPPL -8	View Letter (PDF)
Jun 21, 2005	SUPPL -6	View Letter (PDF)
Sep 17, 2004	SUPPL -5	View Letter (PDF)
May 26, 2004	SUPPL -4	View Letter (PDF)
Jun 8, 2003	SUPPL -2	View Letter (PDF)
Jun 8, 2003	SUPPL -3	View Letter (PDF)
Sep 25, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 25, 2002

No patent or exclusivity listings for this strength.