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Last Updated: August 9, 2020

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COLISTIMETHATE SODIUM Drug Profile

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When do Colistimethate Sodium patents expire, and when can generic versions of Colistimethate Sodium launch?

Colistimethate Sodium is a drug marketed by Emcure Pharms Ltd, Fresenius Kabi Usa, Nexus Pharms, 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. Seven suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

US ANDA 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
Minsk State Clinical Hospital No 9Phase 4
Belarusian state medical universityPhase 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
Emcure Pharms Ltd COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 202359-001 Sep 28, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 201365-001 Feb 19, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065364-001 Apr 17, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Nexus Pharms COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 065177-001 Mar 19, 2004 AP RX No No   Start Trial   Start Trial   Start Trial
Xgen Pharms COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 064216-001 Feb 26, 1999 AP RX No No   Start Trial   Start Trial   Start Trial
Xellia Pharms Aps COLISTIMETHATE SODIUM colistimethate sodium INJECTABLE;INJECTION 205356-001 May 29, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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