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Generated: November 20, 2018

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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 freedom to operate?

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

There are sixteen drug master file entries for piperacillin sodium; tazobactam sodium. Fourteen 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
➤ Sign Up➤ Sign UpEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE;INJECTION
➤ Sign Up➤ Sign Up13.5G/VIALINJECTABLE;INJECTION

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
Mylan Labs Ltd PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 065458-002 Aug 15, 2014 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Qilu Tianhe PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 204959-001 Aug 10, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apollo Pharms Inc PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 207848-001 May 11, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Wyeth Pharms ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-001 Feb 24, 1998 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Federal Trade Commission
Covington
McKinsey
Baxter
Fish and Richardson
Harvard Business School
Colorcon

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