Gramicidin; neomycin sulfate; polymyxin b sulfate - Generic Drug Details

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

Gramicidin; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Dow Pharm, Bausch And Lomb, Ipharm, Nordic Pharma, Watson Labs, Pharmafair, and Monarch Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for gramicidin; neomycin sulfate; polymyxin b sulfate

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
DailyMed Link:	gramicidin; neomycin sulfate; polymyxin b sulfate at DailyMed

Recent Clinical Trials for gramicidin; neomycin sulfate; polymyxin b sulfate

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

Sponsor	Phase
Chulalongkorn University	Phase 3

See all gramicidin; neomycin sulfate; polymyxin b sulfate clinical trials

Pharmacology for gramicidin; neomycin sulfate; polymyxin b sulfate

Drug Class

Aminoglycoside Antibacterial Polymyxin-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for gramicidin; 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

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 gramicidin; 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
Nordic Pharma	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	065187-001	Oct 28, 2005	AT	RX	No	No
Pharmafair	NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	062383-001	Aug 31, 1982		DISCN	No	No
Bausch And Lomb	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	064047-001	Jan 31, 1996	AT	RX	No	Yes
Ipharm	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	062818-001	Oct 11, 1988		DISCN	No	No
Dow Pharm	NEO-POLYCIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	060427-001	Approved Prior to Jan 1, 1982		DISCN	No	No