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Last Updated: November 29, 2023

Piperacillin sodium; tazobactam sodium - Generic Drug Details

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What are the generic 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 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-three NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Piperacillin sodium; tazobactam sodium has forty-one patent family members in thirty-four countries.

Twenty-one suppliers are listed for this compound.

Summary for piperacillin sodium; tazobactam sodium

International Patents:	41
US Patents:	3
Tradenames:	3
Applicants:	14
NDAs:	23
Finished Product Suppliers / Packagers:	21
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

Anatomical Therapeutic Chemical (ATC) Classes for piperacillin sodium; tazobactam sodium

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CG	Beta-lactamase inhibitors
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	206996-003	Mar 22, 2017	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for piperacillin sodium; tazobactam sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-002	Oct 22, 1993	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-004	Oct 22, 1993	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for piperacillin sodium; tazobactam sodium

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2322980	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПИПЕРАЦИЛЛИН И ТАЗОБАКТАМ,ПРИМЕНИМЫЕ ДЛЯ ИНЪЕКЦИИ (PIPERACILLIN AND TAZOBACTAM-CONTAINING COMPOSITIONS USED FOR INJECTION)	⤷ Try a Trial
Costa Rica	8035	COMPOSICIONES QUE CONTIENEN PIPERACILINA Y TAZOBACTAM UTILES PARA INYECCIONES	⤷ Try a Trial
Germany	602004010862		⤷ Try a Trial
Taiwan	200503758	Compositions containing piperacillin and tazobactam useful for injection	⤷ Try a Trial
Argentina	043863	COMPOSICIONES QUE CONTIENEN PIPERACILINA Y TAZOBACTAM, UTILES PARA INYECCIOINES	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.