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	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
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
South Korea	20170134791	제약 화합물의 다형성 및 가다형성 형태 (POLYMORPHIC AND PSEUDOPOLYMORPHIC FORMS OF A PHARMACEUTICAL COMPOUND)
Denmark	3269717
Brazil	0112986	Compostos azabicíclicos, processo para a sua preparação, bem como composições farmacêuticas compreendendo os ditos compostos
Japan	2004505088
Russian Federation	2014101244	СПОСОБ ПОЛУЧЕНИЯ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, ВКЛЮЧАЯ ТРАНС-7-ОКСО-6-(СУЛЬФООКСИ)-1, 6-ДИАЗАБИЦИКЛО[3,2,1]ОКТАН-2-КАРБОКСАМИД И ЕГО СОЛИ
Israel	229815	תהליך להכנת הטרוציקליות הכוללות טרנס- 7 - אוקסו - 6 - (סולפואוקסי) - 1, 6 - דיאזאביציקלו [1,2,3] אוקטאן - 2 - קרבוקסאמיד ומלחים שלהן (Process for preparing heterocyclic compounds including trans-7-oxo- 6 -(sulphooxy)-1, 6 - diazabicyclo [3,2,1] octane- 2-carboxamide and salts thereof)

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	300847	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644	58/2016	Austria		PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
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	1690059-9	Sweden		PRODUCT NAME: PHARMACEUTICAL MIXTURE OR ASSOCIATION THAT INCLUDES AS ACTIVE INGREDIENTS: (1) CEFTAZIDIME OR A SALT THEREOF, AND (2) AVIBACTAM OR A SALT THEREOF; REG. NO/DATE: EU/1/16/1109 20160628
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