PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM - Generic Drug Details

What are the generic sources for prednisolone sodium phosphate; sulfacetamide sodium and what is the scope of freedom to operate?

Prednisolone sodium phosphate; sulfacetamide sodium is the generic ingredient in three branded drugs marketed by Bausch And Lomb, Genus, Epic Pharma Llc, and Novartis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
DailyMed Link:	PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM at DailyMed

Pharmacology for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Drug Class	Corticosteroid Sulfonamide Antibacterial
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AG	Enemas
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
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

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

D10AF	Antiinfectives 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

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

S01AB	Sulfonamides
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

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

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

V03AG	Drugs for treatment of hypercalcemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VASOCIDIN	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	018988-001	Aug 26, 1988		DISCN	Yes	No
Genus	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	073630-001	May 27, 1993		DISCN	No	No
Epic Pharma Llc	SULSTER	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	074511-001	Jul 30, 1996		DISCN	No	No
Bausch And Lomb	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	074449-001	Dec 29, 1995		RX	No	Yes