PIPERACILLIN SODIUM - Generic Drug Details

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

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, 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
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

Sponsor

Phase

M.D. Anderson Cancer Center

Phase 2

Haining Health-Coming Biotech Co., Ltd.

Phase 2

Alphacait, LLC

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	204959-003	Aug 10, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Istituto Bio Ita Spa	PIPERACILLIN	piperacillin sodium	INJECTABLE;INJECTION	065114-002	Nov 14, 2003		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Provepharm Sas	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	207847-001	Jan 13, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Istituto Bio Ita Spa	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	090498-001	May 31, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt Bio Ag	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	207146-001	Mar 17, 2017	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	203557-002	Jul 8, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wyeth Pharms Inc	PIPRACIL	piperacillin sodium	INJECTABLE;INJECTION	050545-006	Sep 30, 1985		DISCN	Yes	No	⤷ 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
Formulation / Manufacturing:	see details
DailyMed Link:	PIPERACILLIN SODIUM at DailyMed