PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM - Generic Drug Details

What are the generic sources for prednisolone acetate; sulfacetamide sodium and what is the scope of patent protection?

Prednisolone acetate; sulfacetamide sodium is the generic ingredient in ten branded drugs marketed by Allergan, Alcon, Schering, Pharmafair, Novartis, Epic Pharma Llc, and Bausch And Lomb, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

US Patents:	0
Tradenames:	10
Applicants:	7
NDAs:	11
DailyMed Link:	PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM at DailyMed

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

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

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

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

US Patents and Regulatory Information for PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	BLEPHAMIDE	prednisolone acetate; sulfacetamide sodium	SUSPENSION;OPHTHALMIC	012813-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pharmafair	PREDSULFAIR	prednisolone acetate; sulfacetamide sodium	OINTMENT;OPHTHALMIC	088032-001	Apr 15, 1983		DISCN	No	No
Pharmafair	PREDSULFAIR II	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088837-001	Dec 24, 1985		DISCN	No	No
Schering	METIMYD	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	010210-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alcon	CETAPRED	prednisolone acetate; sulfacetamide sodium	OINTMENT;OPHTHALMIC	087771-001	Aug 6, 1993		DISCN	No	No
Alcon	ISOPTO CETAPRED	prednisolone acetate; sulfacetamide sodium	SUSPENSION;OPHTHALMIC	087547-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bausch And Lomb	SULPHRIN	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088089-001	Dec 28, 1982		DISCN	No	No