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Last Updated: March 18, 2024

COLISTIMETHATE SODIUM Drug Patent Profile


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Which patents cover Colistimethate Sodium, and what generic alternatives are available?

Colistimethate Sodium is a drug marketed by Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Xgen Pharms. and is included in six NDAs.

The generic ingredient in COLISTIMETHATE SODIUM is colistimethate sodium. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Colistimethate Sodium

A generic version of COLISTIMETHATE SODIUM was approved as colistimethate sodium by XGEN PHARMS on February 26th, 1999.

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Drug patent expirations by year for COLISTIMETHATE SODIUM
Drug Prices for COLISTIMETHATE SODIUM

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Recent Clinical Trials for COLISTIMETHATE SODIUM

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

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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Fresenius Kabi Usa COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065364-001 Apr 17, 2008 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
>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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