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Last Updated: November 2, 2024

COLISTIMETHATE SODIUM - Generic Drug Details


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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
Drug Prices for COLISTIMETHATE SODIUM

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Recent Clinical Trials for COLISTIMETHATE SODIUM

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SponsorPhase
Southeast University, ChinaN/A
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Phase 3
Zambon SpAPhase 3

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
Avet Lifesciences COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 202359-001 Sep 28, 2012 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xellia Pharms Aps COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356-001 May 29, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations COLY-MYCIN M colistimethate sodium INJECTABLE;INJECTION 050108-002 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065364-001 Apr 17, 2008 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adrastea Pharma COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 064216-001 Feb 26, 1999 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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