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				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				Y

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
New Zealand	523707	Azabicyclic compounds, preparations thereof and use as medicines, in particular as antibacterial agents
Canada	2716914	NOUVELLES FORMES CRISTALLINES DU SEL SODIQUE DE TRANS-7-OXO-6-(SULFOXY)-1,6-DIAZABICYCLO¬3,2,1|OCTANE-2-CARBOXAMIDE (NOVEL CRYSTALLINE FORMS OF TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE SODIUM SALT)
South Korea	20200010586	제약 화합물의 다형성 및 가다형성 형태 (POLYMORPHIC AND PSEUDOPOLYMORPHIC FORMS OF A PHARMACEUTICAL COMPOUND)
Portugal	1307457

Supplementary Protection Certificates for avibactam sodium; ceftazidime

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	2016C/069	Belgium		PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628
1480644	122016000105	Germany		PRODUCT NAME: CEFTAZIDIM ODER EIN SALZ DAVON MIT AVIBACTAM ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1109 20160624
1480644	C20160041 00213	Estonia		PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
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