Avibactam sodium; ceftazidime - Generic Drug Details

What are the generic sources for avibactam sodium; ceftazidime and what is the scope of freedom to operate?

Avibactam sodium; ceftazidime is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avibactam sodium; ceftazidime has one hundred and ninety-five patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for avibactam sodium; ceftazidime

International Patents:	195
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	avibactam sodium; ceftazidime at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avibactam sodium; ceftazidime

Dosage:

POWDER;IV (INFUSION)

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for avibactam sodium; ceftazidime

Drug Class	Cephalosporin Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for avibactam sodium; ceftazidime

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for AVIBACTAM SODIUM; CEFTAZIDIME

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVYCAZ	For Injection	avibactam sodium; ceftazidime	0.5 g/2 g per vial	206494	2	2024-02-26

US Patents and Regulatory Information for avibactam sodium; ceftazidime

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes				Y
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes				Y
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes			Y	Y
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes

Expired US Patents for avibactam sodium; ceftazidime

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015

International Patents for avibactam sodium; ceftazidime

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	007220	НОВОЕ ПРИМЕНЕНИЕ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, АКТИВНЫХ В КАЧЕСТВЕ ИНГИБИТОРОВ БЕТА-ЛАКТАМАЗ, И СОДЕРЖАЩИЕ ИХ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (NOVEL HETEROCYCLIC COMPOUNDS, WHICH ARE ACTIVE AS INHIBITORS BETA LACTAMASES, USE THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME)
Jordan	2646	مركبات حلقية متباينة جديدة فعالة كمثبطات لانزيمات بيتا - لاكتام (Novel heterocyclic compounds which are active as inhibitors of beta-lactamases)
Malaysia	165730	PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF
Japan	2014517027
Japan	6023800
Malaysia	140638	NEW HETEROCYCLIC COMPOUNDS, WHICH ARE ACTIVE AS INHIBITORS OF BETA-LACTAMASES

Supplementary Protection Certificates for avibactam sodium; ceftazidime

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	2016/056	Ireland		PRODUCT NAME: A COMBINATION OF CEFTAZIDIME OR A SALT THEREOF, AND AVIBACTAM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644	58/2016	Austria		PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
1480644	C01480644/01	Switzerland		PRODUCT NAME: AVIBACTAM + CEFTAZIDIM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66890 05.06.2019
1480644	93338	Luxembourg		PRODUCT NAME: MELANGE OU ASSOCIATION PHARMACEUTIQUE COMPRENANT COMME INGREDIENTS ACTIFS : (1) CEFTAZIDIME OU UN SEL DE CELUI-CI ET (2) AVIBACTAM OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1109 - ZAVICEFTA - CEFTAZIDIME/AVIBACTAM
1480644	339 5029-2016	Slovakia		PRODUCT NAME: CEFTAZIDIM VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A AVIBAKTAM VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1109 20160628
1307457	C 2016 055	Romania		PRODUCT NAME: AVIBACTAM SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1109; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1109; DATE OF FIRST AUTHORISATION IN EEA: 20160624