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Last Updated: February 25, 2020

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Piperacillin sodium; tazobactam sodium - Generic Drug Details

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

Piperacillin sodium; tazobactam sodium is the generic ingredient in three branded drugs marketed by Apollo, Astral, Aurobindo Pharma Ltd, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Qilu, Sandoz, Sandoz Inc, Wockhardt Bio Ag, and Wyeth Pharms, and is included in twenty NDAs. There are four 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 fifty-four patent family members in thirty-four countries.

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

Summary for piperacillin sodium; tazobactam sodium
International Patents:54
US Patents:4
Tradenames:3
Applicants:13
NDAs:20
Drug Master File Entries: 16
Suppliers / Packagers: 15
Clinical Trials: 4
DailyMed Link:piperacillin sodium; tazobactam sodium at DailyMed
Recent Clinical Trials for piperacillin sodium; tazobactam sodium

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SponsorPhase
St. Justine's HospitalPhase 1
Phillip Brian SmithPhase 1
Merck Sharp & Dohme Corp.Phase 3

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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
Aurobindo Pharma Ltd PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065498-003 May 23, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Astral PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 212287-003 Jul 29, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Istituto Bio Ita Spa PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 090498-001 May 31, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065386-002 Sep 15, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362-002 Oct 21, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Istituto Bio Ita Spa PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065523-003 May 31, 2011 AP RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-002 Feb 24, 1998   Start Trial   Start Trial
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-001 Feb 24, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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 verifification 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.