Piperacillin sodium; tazobactam sodium - Generic Drug Details

What are the generic drug sources for piperacillin sodium; tazobactam sodium and what is the scope of freedom to operate?

Piperacillin sodium; tazobactam sodium is the generic ingredient in three branded drugs marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Wockhardt Bio Ag, Wyeth Pharms, and Baxter Hlthcare Corp, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for piperacillin sodium; tazobactam sodium

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	24
Finished Product Suppliers / Packagers:	17
Clinical Trials:	5
DailyMed Link:	piperacillin sodium; tazobactam sodium at DailyMed

Recent Clinical Trials for piperacillin sodium; tazobactam sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
St. Justine's Hospital	Phase 1
Phillip Brian Smith	Phase 1

See all piperacillin sodium; tazobactam sodium clinical trials

Pharmacology for piperacillin sodium; tazobactam sodium

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Paragraph IV (Patent) Challenges for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOSYN	For Injection	piperacillin sodium; tazobactam sodium	12 g/1.5 g per vial (pharmacy bulk)	050684	1	2011-12-06

US Patents and Regulatory Information for piperacillin sodium; tazobactam sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma Speclts	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065498-003	May 23, 2011	AP	RX	No	No
Shandong	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	204959-001	Aug 10, 2018	AP	RX	No	No
Shandong	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	204959-003	Aug 10, 2018	AP	RX	No	No
Wockhardt Bio Ag	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	206996-002	Mar 22, 2017	AP	RX	No	Yes
Provepharm Sas	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	207847-003	Jan 13, 2017	AP	RX	No	No
Sandoz	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065363-002	Oct 21, 2010	AP	RX	No	No
Astral	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	212287-001	Jul 29, 2019	AP	RX	No	No

Expired US Patents for piperacillin sodium; tazobactam sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-001	Oct 22, 1993
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-001	Oct 22, 1993
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-004	Oct 22, 1993