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 patent protection?

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

Bascom Palmer Eye Institute

N/A

University of Miami

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
Allergan	POLYTRIM	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	050567-001	Oct 20, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	065372-001	Jan 10, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	065006-001	Dec 17, 1998	AT	RX	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
Somerset Theraps Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	211572-001	Aug 5, 2024	AT	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