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COLY-MYCIN S

NDA

COLISTIN SULFATE | N050355 | PARKE DAVIS DIV WARNER LAMBERT CO

1 strength0 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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Colistin Versus Colistin Combined With Cefoperazone-sulbactam for Multiresistant Acinetobactor Baumannii Ventilator-associated Pneumonia Treatment NCT07671755	N/A	Completed	Shaheed Mohtarma Benazir Bhutto Institue of Trauma	80	2025-02-01 → 2026-04-30

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

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

XELLIA PHARMACEUTICALS APSCOLISTIN SULFATE

DMF 133621998

KAYAKU CO LTDInactiveCOLISTIN SULFATE

DMF 132891998

KAYAKU CO LTDInactiveCOLISTIN SULFATE

DMF 133011998

DUMEX ALPHARMA ASInactiveCOLISTIN SULFATE MONOCOMPONENT

DMF 144241999

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

Products (1)

#001 — EQ 25MG BASE/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.