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Last Updated: October 11, 2024

Hydrocortisone acetate - Generic Drug Details


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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
Drug Prices for hydrocortisone acetate

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Recent Clinical Trials for hydrocortisone acetate

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 1
Orion Corporation, Orion PharmaPhase 1
University Medical Center GroningenEarly Phase 1

See all hydrocortisone acetate clinical trials

Pharmacology for hydrocortisone acetate
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride CREAM;TOPICAL 085368-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc COR-OTICIN hydrocortisone acetate; neomycin sulfate SUSPENSION/DROPS;OPHTHALMIC 060188-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmacia And Upjohn NEO-CORTEF hydrocortisone acetate; neomycin sulfate OINTMENT;OPHTHALMIC 060610-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bel Mar HYDROCORTISONE ACETATE hydrocortisone acetate INJECTABLE;INJECTION 083739-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Imperium HYDROCORTISONE ACETATE hydrocortisone acetate CREAM;TOPICAL 040259-001 Jul 29, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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