Last Updated: September 24, 2026

COLISTIN SULFATE - Generic Drug Details

Name: COLISTIN SULFATE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for colistin sulfate and what is the scope of freedom to operate?

Colistin sulfate is the generic ingredient in one branded drug marketed by Parke Davis and Ph Health, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for COLISTIN SULFATE

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2
Clinical Trials:	5
DailyMed Link:	COLISTIN SULFATE at DailyMed

Recent Clinical Trials for COLISTIN SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Madonna Magdy Fahmy	Early Phase 1
National Cancer Institute, Egypt	Phase 4
Cystic Fibrosis Foundation Therapeutics	Phase 1/Phase 2

See all COLISTIN SULFATE clinical trials

Medical Subject Heading (MeSH) Categories for COLISTIN SULFATE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for COLISTIN SULFATE

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XB	Polymyxins
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for COLISTIN SULFATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	COLY-MYCIN S	colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide	SUSPENSION/DROPS;OTIC	050356-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Parke Davis	COLY-MYCIN S	colistin sulfate	SUSPENSION;ORAL	050355-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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