Neomycin sulfate; polymyxin b sulfate - Generic Drug Details

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

Neomycin sulfate; polymyxin b sulfate is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Alcon, Watson Labs, Xgen Pharms, Monarch Pharms, and Allergan, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for neomycin sulfate; polymyxin b sulfate

US Patents:	0
Tradenames:	5
Applicants:	6
NDAs:	9
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	neomycin sulfate; polymyxin b sulfate at DailyMed

Recent Clinical Trials for neomycin sulfate; polymyxin b sulfate

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

Sponsor	Phase
University of Miami	N/A
Bascom Palmer Eye Institute	N/A
Azidus Brasil	Phase 3

See all neomycin sulfate; polymyxin b sulfate clinical trials

Pharmacology for neomycin sulfate; polymyxin b sulfate

Drug Class

Aminoglycoside Antibacterial Polymyxin-class Antibacterial

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

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

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

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

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

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

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XB	Polymyxins
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

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

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

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

US Patents and Regulatory Information for neomycin sulfate; 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
Allergan	POLY-PRED	neomycin sulfate; polymyxin b sulfate; prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	050081-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Monarch Pharms	NEOSPORIN G.U. IRRIGANT	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	060707-001	Approved Prior to Jan 1, 1982	AT	RX	No	Yes
Alcon	STATROL	neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	050344-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Xgen Pharms	NEOMYCIN AND POLYMYXIN B SULFATE	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	065106-001	Jan 31, 2006	AT	RX	No	No