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Last Updated: October 22, 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. Fifteen 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: 15
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
Sagent Pharms Inc PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 208674-002 Feb 16, 2021 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Qilu PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 204959-002 Aug 10, 2018 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206204-001 May 11, 2018 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-001 Oct 22, 1993 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-002 Feb 24, 1998 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sandoz PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065362-002 Oct 21, 2010 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wockhardt Bio Ag PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996-001 Mar 22, 2017 AP RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  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

International Patents for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Country Patent Number Estimated Expiration
Israel 171337 ⤷  Free Forever Trial
United Kingdom 2400557 ⤷  Free Forever Trial
Taiwan 200503758 ⤷  Free Forever Trial
Mexico PA05010996 ⤷  Free Forever Trial
Portugal 1468697 ⤷  Free Forever Trial
Brazil PI0409450 ⤷  Free Forever Trial
Slovenia 1468697 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Dow
Harvard Business School
Merck
Mallinckrodt

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