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Serving leading biopharmaceutical companies globally:

Covington
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Johnson and Johnson
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US Army
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US Department of Justice
Fuji
Argus Health
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Generated: December 15, 2017

DrugPatentWatch Database Preview

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 Apollo Pharms Inc, Aurobindo Pharma Ltd, Hospira Inc, Istituto Bio Ita Spa, Mylan Labs Ltd, Sandoz, Wockhardt Bio Ag, Wyeth Pharms Inc, and Sandoz Inc, and is included in fifteen 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-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 piperacillin sodium; tazobactam sodium

Pharmacology for piperacillin sodium; tazobactam sodium

Tentative approvals for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Applicant Application No. Strength Dosage Form
u► Subscribe13.5G/VIALINJECTABLE;INJECTION
u► 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Istituto Bio Ita SpaPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION065523-002May 31, 2011APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Istituto Bio Ita SpaPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION090498-001May 31, 2011APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION065363-003Oct 21, 2010APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hospira IncPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION065446-001Sep 15, 2009APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Wyeth Pharms IncZOSYN IN PLASTIC CONTAINERpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION050750-002Feb 24, 1998RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Wockhardt Bio AgPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION206996-002Mar 22, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Wyeth Pharms IncZOSYN IN PLASTIC CONTAINERpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION050750-003Feb 24, 1998RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Hospira IncPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION065386-001Sep 15, 2009APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apollo Pharms IncPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION207847-001Jan 13, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Wockhardt Bio AgPIPERACILLIN AND TAZOBACTAMpiperacillin sodium; tazobactam sodiumINJECTABLE;INJECTION206996-001Mar 22, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► 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
Saudi Arabia2083► Subscribe
Austria381947► Subscribe
Austria426404► Subscribe
World Intellectual Property Organization (WIPO)0050035► Subscribe
Malaysia139099► Subscribe
Chile2004000782► Subscribe
South Korea100824554► Subscribe
Canada2361392► Subscribe
Slovenia1468697► Subscribe
Japan2006316075► 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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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Dow
Merck
Citi
Accenture
Novartis
Deloitte
QuintilesIMS
Federal Trade Commission

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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