Colistimethate sodium - Generic Drug Details

What are the generic sources for colistimethate sodium and what is the scope of freedom to operate?

Colistimethate sodium is the generic ingredient in two branded drugs marketed by Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Endo Operations, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for colistimethate sodium. Five suppliers are listed for this compound.

Summary for colistimethate sodium

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	20
Drug Prices:	Drug price trends for colistimethate sodium
What excipients (inactive ingredients) are in colistimethate sodium?	colistimethate sodium excipients list
DailyMed Link:	colistimethate sodium at DailyMed

See drug prices for colistimethate sodium

Recent Clinical Trials for colistimethate sodium

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

Sponsor	Phase
Southeast University, China	N/A
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 3
Zambon SpA	Phase 3

See all colistimethate sodium clinical trials

Pharmacology for colistimethate sodium

Drug Class

Polymyxin-class Antibacterial

US Patents and Regulatory Information for colistimethate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nexus	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065177-001	Mar 19, 2004	AP	RX	No	No
Xellia Pharms Aps	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	205356-001	May 29, 2015	AP	RX	No	No
Avet Lifesciences	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	202359-001	Sep 28, 2012	AP	RX	No	No
Fresenius Kabi Usa	COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065364-001	Apr 17, 2008	AP	RX	No	No

EU/EMA Drug Approvals for colistimethate sodium

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Colobreathe	colistimethate sodium	EMEA/H/C/001225 Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2012-02-13