DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE - Generic Drug Details

What are the generic sources for dexamethasone; neomycin sulfate; polymyxin b sulfate and what is the scope of patent protection?

Dexamethasone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in four branded drugs marketed by Novartis, Pharmafair, Sandoz, Bausch And Lomb, Padagis Us, Harrow Eye, and Alcon Pharms Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	11
Finished Product Suppliers / Packagers:	17
Clinical Trials:	2
DailyMed Link:	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE at DailyMed

Recent Clinical Trials for DEXAMETHASONE; 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 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE clinical trials

Pharmacology for DEXAMETHASONE; 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 DEXAMETHASONE; 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

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

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE 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

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

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL 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

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

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for DEXAMETHASONE; 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
Sandoz	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062341-001	May 22, 1984	AT	RX	No	No
Harrow Eye	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	050023-002	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Novartis	DEXACIDIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062544-001	Oct 29, 1984		DISCN	No	No
Pharmafair	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062428-001	May 18, 1983		DISCN	No	No
Pharmafair	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	062411-001	May 16, 1983		DISCN	No	No
Sandoz	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	050065-002	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes