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Last Updated: March 18, 2024

Colistimethate sodium - Generic Drug Details


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What are the generic drug 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 Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, Xgen Pharms, and Par Sterile Products, 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. Six suppliers are listed for this compound.

Drug Prices for colistimethate sodium

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Recent Clinical Trials for colistimethate sodium

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

SponsorPhase
Zambon SpAPhase 3
Belarusian State Medical UniversityPhase 4
Minsk State Clinical Hospital No 9Phase 4

See all colistimethate sodium clinical trials

Pharmacology for colistimethate sodium

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
Sagent Pharms Inc COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 201365-001 Feb 19, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nexus COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065177-001 Mar 19, 2004 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xellia Pharms Aps COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356-001 May 29, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avet Lifesciences COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 202359-001 Sep 28, 2012 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products COLY-MYCIN M colistimethate sodium INJECTABLE;INJECTION 050108-002 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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