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

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

Hydrocortisone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in nine branded drugs marketed by Monarch Pharms, Amring Pharms, Bausch And Lomb, Sandoz, Pharmafair, Watson Labs, Casper Pharma Llc, Schering, and Actavis Labs Fl Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for hydrocortisone; neomycin sulfate; polymyxin b sulfate

US Patents:	0
Tradenames:	9
Applicants:	9
NDAs:	18
Finished Product Suppliers / Packagers:	16
DailyMed Link:	hydrocortisone; neomycin sulfate; polymyxin b sulfate at DailyMed

Pharmacology for hydrocortisone; neomycin sulfate; polymyxin b sulfate

Drug Class	Aminoglycoside Antibacterial Corticosteroid Polymyxin-class Antibacterial
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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

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

A01AC	Corticosteroids 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

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
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

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

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

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

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

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
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 hydrocortisone; 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
Pharmafair	NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	062617-001	Sep 18, 1985		DISCN	No	No
Bausch And Lomb	OTICAIR	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	064065-001	Aug 28, 1996	AT	RX	No	No
Monarch Pharms	CORTISPORIN	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	050169-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Actavis Labs Fl Inc	OTOCORT	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	062521-001	Jul 11, 1985		DISCN	No	No
Monarch Pharms	CORTISPORIN	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OTIC	050479-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmafair	OTICAIR	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	062399-001	Nov 18, 1982		DISCN	No	No
Amring Pharms	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OTIC	065219-001	May 1, 2006	AT	RX	No	No