Acetic acid, glacial; hydrocortisone - Generic Drug Details

What are the generic sources for acetic acid, glacial; hydrocortisone and what is the scope of freedom to operate?

Acetic acid, glacial; hydrocortisone is the generic ingredient in six branded drugs marketed by Actavis Mid Atlantic, Kv Pharm, Bausch And Lomb, Cosette, Taro, Wockhardt, Warner Chilcott, Saptalis Pharms, and Bayer Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for acetic acid, glacial; hydrocortisone

US Patents:	0
Tradenames:	6
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	acetic acid, glacial; hydrocortisone at DailyMed

Pharmacology for acetic acid, glacial; hydrocortisone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for acetic acid, glacial; hydrocortisone

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

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

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

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

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for acetic acid, glacial; hydrocortisone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	NEO-CORT-DOME	acetic acid, glacial; hydrocortisone; neomycin sulfate	SUSPENSION/DROPS;OTIC	050238-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Saptalis Pharms	VOSOL HC	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	012770-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Kv Pharm	ACETIC ACID W/ HYDROCORTISONE	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	085492-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wockhardt	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040168-001	Aug 30, 1996		DISCN	No	No
Warner Chilcott	ORLEX HC	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	086844-001	Approved Prior to Jan 1, 1982		DISCN	No	No