Hydrocortisone acetate - Generic Drug Details

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

Hydrocortisone acetate is the generic ingredient in nineteen branded drugs marketed by Mylan Speciality Lp, Fougera Pharms, Able, Cenci, Imperium, Parke Davis, Purepac Pharm, Sebela Ireland Ltd, Taro, Pharmacia And Upjohn, Pfizer, Bel Mar, Epic Pharma Llc, Watson Labs, Merck, Ingram Pharm, Fera Pharms, Colgate, X Gen Pharms, Monarch Pharms, Genus, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for hydrocortisone acetate. Two suppliers are listed for this compound.

Summary for hydrocortisone acetate

US Patents:	0
Tradenames:	19
Applicants:	22
NDAs:	40
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	20
Patent Applications:	7,082
Drug Prices:	Drug price trends for hydrocortisone acetate
What excipients (inactive ingredients) are in hydrocortisone acetate?	hydrocortisone acetate excipients list
DailyMed Link:	hydrocortisone acetate at DailyMed

See drug prices for hydrocortisone acetate

Recent Clinical Trials for hydrocortisone acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Orion Corporation, Orion Pharma	Phase 1
Merck Sharp & Dohme LLC	Phase 1
University Medical Center Groningen	Early Phase 1

See all hydrocortisone acetate clinical trials

Pharmacology for hydrocortisone acetate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone acetate

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bel Mar	HYDROCORTISONE ACETATE	hydrocortisone acetate	INJECTABLE;INJECTION	083739-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	HYDROCORTISONE ACETATE	hydrocortisone acetate	INJECTABLE;INJECTION	009637-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	NEO-CORTEF	hydrocortisone acetate; neomycin sulfate	OINTMENT;OPHTHALMIC	060610-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	NEO-CORTEF	hydrocortisone acetate; neomycin sulfate	OINTMENT;TOPICAL	060751-003	Approved Prior to Jan 1, 1982		DISCN	No	No