Piperacillin sodium - Generic Drug Details
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What are the generic sources for piperacillin sodium and what is the scope of freedom to operate?
Piperacillin sodium
is the generic ingredient in five branded drugs marketed by Istituto Bio Ita Spa, Wyeth Pharms Inc, Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Wockhardt Bio Ag, Wyeth Pharms, and Baxter Hlthcare Corp, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for piperacillin sodium.
Summary for piperacillin sodium
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 16 |
| NDAs: | 28 |
| Drug Master File Entries: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 11 |
| Patent Applications: | 6,302 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | piperacillin sodium at DailyMed |
Recent Clinical Trials for piperacillin sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| Alphacait, LLC | Phase 2 |
Medical Subject Heading (MeSH) Categories for piperacillin sodium
US Patents and Regulatory Information for piperacillin sodium
| 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 | PIPRACIL | piperacillin sodium | INJECTABLE;INJECTION | 050545-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sagent Pharms Inc | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 208674-002 | Feb 16, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | ZOSYN IN PLASTIC CONTAINER | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 050750-001 | Feb 24, 1998 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sagent Pharms Inc | PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 208675-001 | Feb 16, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
