Piperacillin sodium - Generic Drug Details

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What are the generic sources for piperacillin sodium and what is the scope of patent protection?

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

There are four drug master file entries for piperacillin sodium.

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

Sponsor

Phase

M.D. Anderson Cancer Center

Phase 2

Alphacait, LLC

Phase 2

Haining Health-Coming Biotech Co., Ltd.

Phase 2

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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
Shandong	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	204959-002	Aug 10, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	203719-002	May 18, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Shandong	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	204959-003	Aug 10, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astral	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	212287-001	Jul 29, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Istituto Bio Ita Spa	PIPERACILLIN	piperacillin sodium	INJECTABLE;INJECTION	065157-001	Jul 12, 2004		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	16
NDAs:	28
Drug Master File Entries:	4
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	11
Patent Applications:	6,302
DailyMed Link:	piperacillin sodium at DailyMed