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Last Updated: March 28, 2024

HYDROCORTONE Drug Patent Profile


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Which patents cover Hydrocortone, and what generic alternatives are available?

Hydrocortone is a drug marketed by Merck and is included in four NDAs.

The generic ingredient in HYDROCORTONE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydrocortone

A generic version of HYDROCORTONE was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Drug patent expirations by year for HYDROCORTONE
Recent Clinical Trials for HYDROCORTONE

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SponsorPhase
National Cancer Institute (NCI)Phase 1
Children's Oncology GroupPhase 1
EsPhALL network I-BFM Study GroupPhase 3

See all HYDROCORTONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTONE
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 HYDROCORTONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck HYDROCORTONE hydrocortisone acetate INJECTABLE;INJECTION 008228-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck HYDROCORTONE hydrocortisone acetate OINTMENT;OPHTHALMIC, OTIC 009018-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck HYDROCORTONE hydrocortisone acetate INJECTABLE;INJECTION 008228-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck HYDROCORTONE hydrocortisone sodium phosphate INJECTABLE;INJECTION 012052-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for HYDROCORTONE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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