cefepime hydrochloride; zidebactam - Profile

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What are the generic drug sources for cefepime hydrochloride; zidebactam and what is the scope of freedom to operate?

Cefepime hydrochloride; zidebactam is the generic ingredient in one branded drug marketed by Wockhardt Bio Ag and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for cefepime hydrochloride; zidebactam

International Patents:	61
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cefepime hydrochloride; zidebactam

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cefepime hydrochloride; zidebactam

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

^*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.

US Patents and Regulatory Information for cefepime hydrochloride; zidebactam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	9,132,133
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	9,827,235		Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	9,834,557			Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	9,657,021			Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	8,853,197			Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	9,381,200		Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes	8,822,450		Y	Y

International Patents for cefepime hydrochloride; zidebactam

Country	Patent Number	Title	Estimated Expiration
Australia	2012303691	1,6- diazabicyclo [3,2,1] octan-7-one derivatives and their use in the treatment of bacterial infections
Brazil	112013028813	derivados de 1,6-diazabiciclo[3,2,1]octan-7-ona e seu uso no tratamento de infecções bacterianas
Canada	2833241	DERIVES 1,6-DIAZABICYCLO[3,2,1]OCTANE-7-ONE ET LEUR UTILISATION DANS LE TRAITEMENT D'INFECTIONS BACTERIENNES (1,6- DIAZABICYCLO [3,2,1] OCTAN-7-ONE DERIVATIVES AND THEIR USE IN THE TREATMENT OF BACTERIAL INFECTIONS)
China	103619843	1，6‑二氮杂双环[3，2，1]辛‑7‑酮衍生物及其在治疗细菌感染中的用途 (1,6-diazabicyclo[3,2,1]octan-7-one derivatives and use thereof in treating bacterial infections)
Denmark	2748165
European Patent Office	2748165	DÉRIVÉS 1,6-DIAZABICYCLO[3,2,1]OCTANE-7-ONE ET LEUR UTILISATION DANS LE TRAITEMENT D'INFECTIONS BACTÉRIENNES (1,6-DIAZABICYCLO[3,2,1]OCTAN-7-ONE DERIVATIVES AND THEIR USE IN THE TREATMENT OF BACTERIAL INFECTIONS.)
Spain	2603198