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MAXIPIME

NDA

CEFEPIME HYDROCHLORIDE | N050679 | HOSPIRA INC

3 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
Samson Medical Technologies, L.L.C - Citizen Petition FDA-2008-P-0539 · 3 docket documents Samson Medical Technologies, L.L.C. filed this petition under 21 CFR 314.93 on September 25, 2008, requesting permission to file an Abbreviated New Drug Application for Cefepime for Injection, USP in a 100 gram pharmacy bulk package strength, which differs from Bristol-Myers Squibb's reference liste	Other	2008-10-10	Granted	—
Citizen Petition from B. Braun Medical, Inc. FDA-2006-P-0015 · 11 docket documents B. Braun Medical Inc. filed this suitability petition requesting that the FDA declare Cefepime for Injection, administered intravenously only, is suitable for submission as an Abbreviated New Drug Application under 21 CFR 314.92, using Maxipime as the reference listed drug, with proposed labeling ba	Other	2008-06-23	Withdrawn	B. Braun Medical, Inc.

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

Clinical Trials

36 trials from ClinicalTrials.gov, 1 active, 23 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant NCT03078010	Phase 2	Active	Memorial Sloan Kettering Cancer Center	347	2017-02-10 → 2027-02
Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam NCT03485950	Phase 2	Completed	M.D. Anderson Cancer Center	100	2018-05-16 → 2022-02-16
Individualized Cefepime Dosing Study NCT02680600	N/A	Completed	Onze Lieve Vrouw Hospital	20	2014-03 → 2016-01
Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)NCT02497781	Phase 2	Completed	Pfizer	97	2015-09-24 → 2017-09-15
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects NCT03680352	Phase 1	Completed	Allecra	30	2017-09-01 → 2018-12-30
Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers NCT03685084	Phase 1	Completed	Allecra	56	2013-10-10 → 2014-01-13
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen NCT00609375	Phase 4	Completed	Javeriana University	30	2006-09 → 2007-12
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime NCT02532140	Phase 1	Completed	Wockhardt	88	2015-08 → 2015-12
Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated Peritonitis NCT02872038	Phase 4	Completed	Chulalongkorn University	154	2015-08 → 2016-11-30
Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae NCT02795949	Phase 3	Completed	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	344	2016-10 → 2020-01

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

API Supply Chain7 active DMFs4 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

ORCHID PHARMA LTDCEFEPIME HYDROCHLORIDE (STERILE BULK)

DMF 189022005

ANTIBIOTICOS DO BRASIL LTDACEFEPIME FOR INJECTION USP (STERILE BULK)

DMF 198062006

ACS DOBFAR SPACEFEPIME FOR INJECTION (STERILE BULK)

DMF 243952011

NECTAR LIFESCIENCES LTDCEFEPIME HYDROCHLORIDE USP (STERILE)

DMF 250162012

NECTAR LIFESCIENCES LTDCEFEPIME HYDROCHLORIDE (NON-STERILE)

DMF 250172011

QILU ANTIBIOTICS PHARMACEUTICAL CO LTDCEFEPIME FOR INJECTION

DMF 253032011

FRESENIUS KABI IPSUM SRLCEFEPIME HYDROCHLORIDE STERILE

DMF 279712014

AUROBINDO PHARMA LTDInactiveCEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE

DMF 194782006

AUROBINDO PHARMA LTDInactiveCEFEPIME FOR INJECTION USP (STERILE BULK)

DMF 197552006

ACS DOBFAR SPAInactiveCEFEPIME HYDROCHLORIDE ORAL GRADE

DMF 199272006

SANDOZ GMBHInactiveCefepime, unsterile

DMF 211392007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Aug 12, 2021	SUPPL -46	View Letter (PDF)
May 9, 2017	SUPPL -42	View Letter (PDF)
Mar 3, 2016	SUPPL -40	View Letter (PDF)
May 6, 2014	SUPPL -31	View Letter (PDF)
Mar 18, 2013	SUPPL -34	View Letter (PDF)
Sep 10, 2012	SUPPL -36	View Letter (PDF)
Nov 20, 2009	SUPPL -32	View Letter (PDF)
Nov 26, 2007	SUPPL -24	View Letter (PDF)
Jun 10, 2004	SUPPL -23	View Letter (PDF)
Mar 26, 2003	SUPPL -21	View Letter (PDF)
Aug 21, 2002	SUPPL -9	View Letter (PDF)
Aug 21, 2002	SUPPL -18	View Letter (PDF)
Aug 21, 2002	SUPPL -14	View Letter (PDF)
Jan 27, 1999	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 18, 1996

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 18, 1996

#003 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 18, 1996