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Piperacillin sodium; tazobactam sodium - Generic Drug Details

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Piperacillin sodium; tazobactam sodium is the generic ingredient in three branded drugs marketed by Istituto Bio Ita Spa, Hospira Inc, Wyeth Pharms Inc, Sandoz Inc, Mylan Labs Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in eleven NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-six patent family members in thirty-two countries.

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

Summary for Generic Name: piperacillin sodium; tazobactam sodium

Tradenames:3
Patents:4
Applicants:7
NDAs:11
Drug Master File Entries: see list14
Suppliers / Packaging: see list10
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: piperacillin sodium; tazobactam sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc
ZOSYN IN PLASTIC CONTAINER
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION050750-003Feb 24, 1998RXYes8,133,883► subscribeY ► subscribe
Sandoz
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION065362-003Oct 21, 2010RXNo► subscribe► subscribe
Wyeth Pharms Inc
ZOSYN
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION050684-003Oct 22, 1993RXYes8,133,883► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: piperacillin sodium; tazobactam sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,498,312Compositions containing piperacillin and tazobactam useful for injection► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: piperacillin sodium; tazobactam sodium

Country Document Number Estimated Expiration
Switzerland695185► subscribe
European Patent Office1154770► subscribe
Costa Rica8035► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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