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, and Sandoz, and is included in fourteen 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
Eugia Pharma	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	206589-001	Apr 4, 2016	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gland	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	207322-001	Apr 14, 2016	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adrastea Pharma	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	063000-001	Sep 30, 1994	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064211-001	Apr 13, 1998	AT	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xellia Pharms Aps	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	202766-001	Jan 15, 2014	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	14
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	6
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