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Last Updated: September 20, 2021

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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, Aurobindo Pharma Ltd, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Provepharm Sas, Qilu, Sagent Pharms Inc, Sandoz, Sandoz Inc, Wockhardt Bio Ag, and Wyeth Pharms, and is included in twenty-two 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.

There are sixteen drug master file entries for piperacillin sodium; tazobactam sodium. Fourteen suppliers are listed for this compound.

Summary for piperacillin sodium; tazobactam sodium
International Patents:41
US Patents:3
Tradenames:3
Applicants:14
NDAs:22
Drug Master File Entries: 16
Finished Product Suppliers / Packagers: 14
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

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
St. Justine's HospitalPhase 1
Phillip Brian SmithPhase 1

See all piperacillin sodium; tazobactam sodium clinical trials

Pharmacology for piperacillin sodium; tazobactam sodium
Paragraph IV (Patent) Challenges for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ZOSYN INJECTABLE;INJECTION piperacillin sodium; tazobactam sodium 050684 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
Istituto Bio Ita Spa PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065523-001 May 31, 2011 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira Inc PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065386-001 Sep 15, 2009 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 203719-003 May 18, 2018 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-002 Oct 22, 1993 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-003 Feb 24, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-001 Feb 24, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-002 Feb 24, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Merck
McKesson
Mallinckrodt
Johnson and Johnson

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.