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Bacitracin zinc; polymyxin b sulfate - Generic Drug Details

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

Bacitracin zinc; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Akorn, Bausch And Lomb, Padagis Us, Pharmafair, Monarch Pharms, and Naska, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for bacitracin zinc; polymyxin b sulfate. Eight suppliers are listed for this compound.

Summary for bacitracin zinc; polymyxin b sulfate

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	8
Clinical Trials:	1
DailyMed Link:	bacitracin zinc; polymyxin b sulfate at DailyMed

Recent Clinical Trials for bacitracin zinc; polymyxin b sulfate

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

Sponsor	Phase
Glaxo Wellcome	N/A
National Institute of Allergy and Infectious Diseases (NIAID)	N/A

See all bacitracin zinc; polymyxin b sulfate clinical trials

Pharmacology for bacitracin zinc; polymyxin b sulfate

Drug Class	Polymyxin-class Antibacterial
Physiological Effect	Decreased Cell Wall Synthesis & Repair

Anatomical Therapeutic Chemical (ATC) Classes for bacitracin zinc; polymyxin b sulfate

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01XB	Polymyxins
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

R02AB	Antibiotics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for bacitracin zinc; 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
Akorn	BACITRACIN ZINC AND POLYMYXIN B SULFATE	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064028-001	Jan 30, 1995	AT	RX	No	No
Pharmafair	OCUMYCIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	062430-001	Apr 8, 1983		DISCN	No	No
Monarch Pharms	POLYSPORIN	bacitracin zinc; polymyxin b sulfate	OINTMENT;OPHTHALMIC	061229-001	Approved Prior to Jan 1, 1982		DISCN	No	No