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Last Updated: March 2, 2021

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POLYMYXIN B SULFATE Drug Profile

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When do Polymyxin B Sulfate patents expire, and what generic alternatives are available?

Polymyxin B Sulfate is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Asi, West-ward Pharms Int, Xellia Pharms Aps, Xgen Pharms, and Paddock Llc. and is included in eight NDAs.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Polymyxin B Sulfate

A generic version of POLYMYXIN B SULFATE was approved as polymyxin b sulfate by XGEN PHARMS on September 30th, 1994.

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Drug patent expirations by year for POLYMYXIN B SULFATE
Recent Clinical Trials for POLYMYXIN B SULFATE

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SponsorPhase
DongGuk UniversityN/A
Azidus BrasilPhase 3
Chulalongkorn UniversityPhase 3

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Pharmacology for POLYMYXIN B SULFATE
Medical Subject Heading (MeSH) Categories for POLYMYXIN B SULFATE

US Patents and Regulatory Information for POLYMYXIN B SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 206589-001 Apr 4, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Xgen Pharms POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 063000-001 Sep 30, 1994 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Asi POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 090110-001 Jun 29, 2011 DISCN 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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