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

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				Y
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

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
Hong Kong	1196615	製備包括反式- -氧- 磺酰氧基 -二氮二環 辛烷- -氨甲酰及其鹽的雜環化合物的方法 (PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6- (SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF -7--6-()-16-[321]-2-)
Montenegro	00060	NOVA HETEROCIKLIČNA JEDINJENJA, NJIHOVO DOBIJANJE I NJIHOVA UPOTREBA KAO MEDIKAMENATA, A NAROČITO KAO ANTI-BAKTERIJSKIH AGENASA (AZABICYCLIC COMPOUNDS, PREPARATION THEREOF AND USE AS MEDICINES, IN PARTICULAR AS ANTIBACTERIAL AGENTS)
Poland	3269717
World Intellectual Property Organization (WIPO)	2011042560
Eurasian Patent Organization	200300211

Supplementary Protection Certificates for avibactam sodium; ceftazidime

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	SPC/GB17/004	United Kingdom		PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
1480644	132016000125850	Italy		PRODUCT NAME: MISCELA O ASSOCIAZIONE FARMACEUTICA CHE COMPRENDE COME PRINCIPI ATTIVI: (1) CEFTAZIDIMA O UN SUO SALE, E (2) AVIBACTAM O UN SUO SALE(ZAVICEFTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1109, 20160628
1480644	16C1019	France		PRODUCT NAME: ASSOCIATION OU MELANGE PHARMACEUTIQUE RENFERMANT EN TANT QU'INGREDIENTS ACTIFS:(1) LA CEFTAZIDIME OU UN DES SES SELS ET (2) L'AVIBACTAM OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/16/1109 20160628
1480644	C20160041 00213	Estonia		PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
1480644	PA2016037,C1480644	Lithuania		PRODUCT NAME: FARMACINIS MISINYS ARBA DERINYS, APIMANTIS KAIP VEIKLIUOSIUS INGREDIENTUS (1) CEFTAZIDIMA ARBA JO DRUSKA IR (2) AVIBAKTAMA ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624