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Last Updated: March 2, 2021

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Polymyxin b sulfate - Generic Drug Details

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What are the generic drug sources for polymyxin b sulfate and what is the scope of freedom to operate?

Polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Asi, West-ward Pharms Int, Xellia Pharms Aps, Xgen Pharms, X Gen Pharms, Paddock Llc, Allergan, Akorn Inc, Bausch And Lomb, and Sandoz Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for polymyxin b sulfate. Six suppliers are listed for this compound.

Summary for polymyxin b sulfate
US Patents:0
Drug Master File Entries: 12
Suppliers / Packagers: 6
Bulk Api Vendors: 62
Clinical Trials: 4
Patent Applications: 2
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in polymyxin b sulfate?polymyxin b sulfate excipients list
DailyMed Link:polymyxin b sulfate at DailyMed
Recent Clinical Trials for polymyxin b sulfate

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

DongGuk UniversityN/A
Azidus BrasilPhase 3
Chulalongkorn UniversityPhase 3

See all polymyxin b sulfate clinical trials

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
Gland Pharma Ltd POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322-001 Apr 14, 2016 AP RX No Yes   Start Trial   Start Trial   Start Trial
Xellia Pharms Aps POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 202766-001 Jan 15, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline AEROSPORIN polymyxin b sulfate INJECTABLE;INJECTION 062036-001 Approved Prior to Jan 1, 1982 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

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