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Generated: June 28, 2017

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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 piperacillin sodium; tazobactam sodium patent protection?

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

There are fourteen drug master file entries for piperacillin sodium; tazobactam sodium. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: piperacillin sodium; tazobactam sodium

Tradenames:3
Patents:5
Applicants:9
NDAs:15
Drug Master File Entries: see list14
Suppliers / Packagers: see list13
Clinical Trials: see list2,412
Therapeutic Class:Antibacterials
Drug Prices:see low prices
DailyMed Link:piperacillin sodium; tazobactam sodium at DailyMed

Pharmacology for Ingredient: piperacillin sodium; tazobactam sodium

Tentative approvals for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe13.5G/VIALINJECTABLE;INJECTION
► Subscribe► SubscribeEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc
ZOSYN
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION050684-002Oct 22, 1993APRXYesYes7,915,229► SubscribeY ► Subscribe
Mylan Labs Ltd
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION065458-001Aug 15, 2014APRXNoNo► Subscribe► Subscribe
Hospira Inc
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION065386-001Sep 15, 2009APRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
PIPERACILLIN AND TAZOBACTAM
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION065458-003Aug 15, 2014APRXNoNo► Subscribe► Subscribe
Wyeth Pharms Inc
ZOSYN
piperacillin sodium; tazobactam sodium
INJECTABLE;INJECTION050684-003Oct 22, 1993APRXYesYes8,133,883► 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
Malaysia139099► Subscribe
Costa Rica9792► Subscribe
South Korea100824554► Subscribe
EcuadorSP056100► Subscribe
Portugal1468697► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Merck
McKesson
McKinsey
Citi
Medtronic
Queensland Health
Cerilliant
Mallinckrodt
Accenture

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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