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COLY-MYCIN M

NDA

COLISTIMETHATE SODIUM | N050108 | PH HEALTH LTD

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmaceutical Resources Group (PRG) Consulting FDA-2005-P-0441 · 4 docket documents Pharmaceutical Resources Group Consulting filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an ANDA for Colistimethate Sodium 150 mg/2 mL Solution, a sterile preservative-free solution formulation of the reference listed dr	Other	2018-06-21	Granted	Pharmaceutical Resources Group (PRG) Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

14 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)NCT01970371	Phase 3	Completed	Achaogen, Inc.	69	2014-09-16 → 2016-09-15
Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)NCT03093974	Phase 3	Completed	Zambon SpA	377	2017-06-06 → 2021-04-09
Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem NCT01732250	Phase 4	Completed	Mical Paul	406	2013-03 → 2017-02-28
Phase I Study of Colistin Methanesulfonate Sodium NCT01449838	Phase 1	Completed	GlaxoSmithKline	22	2010-10-23 → 2010-12-09
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections NCT03397914	Phase 4	Completed	National Cancer Institute, Egypt	70	2017-01 → 2019-03
A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)NCT02966457	Phase 4	Completed	Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology	62	2017-01 → 2017-12
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)NCT01844778	Phase 4	Completed	Novartis Pharmaceuticals	60	2013-08 → 2015-10
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)NCT02452047	Phase 3	Completed	Merck Sharp & Dohme LLC	50	2015-08-21 → 2017-09-18
Colistin and Rifampicin for MDR-Acinetobacter NCT01577862	Phase 3	Completed	University of Campania Luigi Vanvitelli	210	2008-11 → 2011-10
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)NCT01597973	Phase 3	Completed	University of Michigan	467	2012-10-06 → 2020-08-09

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$5.20

Highest Price

$11.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42023-0107-01COLISTIMETHATE NA 150MG/VIL INJ	$11.82	FSS	Endo USA, Inc.	09/30/2026
42023-0107-01COLISTIMETHATE NA 150MG/VIL INJ	$5.20	Big4	Endo USA, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs

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

XELLIA PHARMACEUTICALS APSCOLISTIMETHATE SODIUM USP

DMF 133631998

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDCOLISTIMETHATE SODIUM

DMF 283502014

HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO LTDCOLISTIMETHATE SODIUM

DMF 351772020

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2025	SUPPL -41	View Letter (PDF)
Apr 18, 2017	SUPPL -33	View Letter (PDF)
Mar 8, 2013	SUPPL -30	View Letter (PDF)
May 19, 2009	SUPPL -26	View Letter (PDF)
Jan 20, 2006	SUPPL -24	View Letter (PDF)
Jun 1, 2004	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 150MG BASE/VIAL

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.