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, Adrastea Pharma, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Rising, Xellia Pharms Aps, X Gen Pharms, Paddock Llc, Allergan, Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for polymyxin b sulfate. Seven suppliers are listed for this compound.

Sponsor

Phase

Madonna Magdy Fahmy

Early Phase 1

University of Miami

N/A

Bascom Palmer Eye Institute

N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Paddock Llc	POLYMYXIN B SULFATE	polymyxin b sulfate	POWDER;FOR RX COMPOUNDING	062455-001	Jul 27, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
X Gen Pharms	POLY-RX	polymyxin b sulfate	POWDER;FOR RX COMPOUNDING	061578-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	060716-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	202766-001	Jan 15, 2014	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Adrastea Pharma	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	063000-001	Sep 30, 1994	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

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	15
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	6
What excipients (inactive ingredients) are in polymyxin b sulfate?	polymyxin b sulfate excipients list
DailyMed Link:	polymyxin b sulfate at DailyMed