HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for hydrocortisone acetate; pramoxine hydrochloride and what is the scope of freedom to operate?

Hydrocortisone acetate; pramoxine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan Speciality Lp, Genus, Sebela Ireland Ltd, and Ferndale Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	4
NDAs:	8
Finished Product Suppliers / Packagers:	4
DailyMed Link:	HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE at DailyMed

Pharmacology for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

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

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

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

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	083778-001	Approved Prior to Jan 1, 1982		RX	No	No
Ferndale Labs	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	LOTION;TOPICAL	083213-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Genus	HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	089440-001	May 17, 1988		DISCN	No	No
Mylan Speciality Lp	PROCTOFOAM HC	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086195-001	Approved Prior to Jan 1, 1982	BX	RX	Yes	Yes
Mylan Speciality Lp	EPIFOAM	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086457-001	Approved Prior to Jan 1, 1982	BX	RX	No	No
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	LOTION;TOPICAL	085980-001	Approved Prior to Jan 1, 1982		RX	No	No
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	LOTION;TOPICAL	085979-001	Approved Prior to Jan 1, 1982		RX	No	No