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PIPRACIL

NDA

PIPERACILLIN SODIUM | N050545 | WYETH PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS NCT07675018	N/A	Not Yet Recruiting	University Hospital, Limoges	204	2026-09-15 → 2028-09-21
Population Pharmacokinetic Modeling to Optimize the Dosage of the Piperacillin / Tazobactam Combination in Patients With Sepsis in Intensive Care NCT03748095	—	Completed	University Hospital, Rouen	91	2019-03-12 → 2023-09-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

SANDOZ INDUSTRIAL PRODUCTS SAPIPERACILLIN SODIUM & TAZOBACTAM SODIUM (8:1), STERILE

DMF 189032005

SHANDONG ANXIN PHARMACEUTICAL CO LTDPIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1)

DMF 204322007

SHANDONG ANXIN PHARMACEUTICAL CO LTDPIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API)

DMF 260092012

SHANDONG ANXIN PHARMACEUTICAL CO LTDPIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (PROCESS IV)

DMF 335402019

RAJASTHAN ANTIBIOTICS LTDPIPERACILLIN SODIUM AND TAZOBACTAM SODIUM STERILE (8:1)

DMF 408772024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Apr 22, 2008	SUPPL -53	View Letter (PDF)
Jul 29, 2005	SUPPL -52	View Letter (PDF)
Jul 29, 2005	SUPPL -51	View Letter (PDF)
Apr 7, 2004	SUPPL -50	View Letter (PDF)
Jun 8, 2003	SUPPL -31	View Letter (PDF)
Jun 8, 2003	SUPPL -37	View Letter (PDF)
Jun 8, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#002 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#006 — EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 30, 1985