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, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience Speclts, Wockhardt Bio Ag, Wyeth Pharms, and Baxter Hlthcare Corp, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.Sixteen suppliers are listed for this compound.
Summary for piperacillin sodium; tazobactam sodium
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 15 |
| NDAs: | 24 |
| Finished Product Suppliers / Packagers: | 16 |
| 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
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| St. Justine's Hospital | Phase 1 |
| Phillip Brian Smith | Phase 1 |
See all piperacillin sodium; tazobactam sodium clinical trials
Pharmacology for piperacillin sodium; tazobactam sodium
| Drug Class | Penicillin-class Antibacterial beta Lactamase Inhibitor |
| Mechanism of Action | beta Lactamase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for piperacillin sodium; tazobactam sodium
Paragraph IV (Patent) Challenges for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZOSYN | For Injection | piperacillin sodium; tazobactam sodium | 12 g/1.5 g per vial (pharmacy bulk) | 050684 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 065362-002 | Oct 21, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 206204-001 | May 11, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Provepharm Sas | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 207848-002 | Jan 13, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Shandong | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 204959-002 | Aug 10, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 203720-001 | May 11, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira Inc | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 065386-002 | Sep 15, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wockhardt Bio Ag | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 206996-003 | Mar 22, 2017 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | ZOSYN IN PLASTIC CONTAINER | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050750-003 | Feb 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare Corp | ZOSYN IN PLASTIC CONTAINER | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050750-003 | Feb 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | ZOSYN | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050684-004 | Oct 22, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | ZOSYN | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050684-001 | Oct 22, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare Corp | ZOSYN IN PLASTIC CONTAINER | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050750-001 | Feb 24, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | ZOSYN | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050684-002 | Oct 22, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | ZOSYN | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050684-002 | Oct 22, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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 verification 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.
ISSN: 2162-2639
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