HYDROCORTISONE - Generic Drug Details

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

Hydrocortisone is the generic ingredient in seventy-six branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Chartwell, Ani Pharms, Teva Pharms, Healthpoint, Eton, Pharmacia And Upjohn, Baker Norton, Legacy Pharma, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Paddock Llc, Mission Pharma, Pfizer, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Imperium, Sebela Ireland Ltd, Bel Mar, Epic Pharma Llc, Fera Pharms, Colgate, Genus, Ferndale Labs, Glenmark Pharms Ltd, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, Cosette, Encube Ethicals, Padagis Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-six patent family members in twenty-five countries.

There are sixty-seven drug master file entries for hydrocortisone. Thirty-nine suppliers are listed for this compound.

Summary for HYDROCORTISONE

International Patents:	56
US Patents:	4
Tradenames:	76
Applicants:	111
NDAs:	259
Drug Master File Entries:	67
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	444
Drug Prices:	Drug price trends for HYDROCORTISONE
Drug Sales Revenues:	Drug sales revenues for HYDROCORTISONE
What excipients (inactive ingredients) are in HYDROCORTISONE?	HYDROCORTISONE excipients list
DailyMed Link:	HYDROCORTISONE at DailyMed

See drug prices for HYDROCORTISONE

See drug sales revenues for HYDROCORTISONE

Recent Clinical Trials for HYDROCORTISONE

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

See all HYDROCORTISONE clinical trials

Pharmacology for HYDROCORTISONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for HYDROCORTISONE

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for 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

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

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	210307-001	Aug 15, 2019	AB	RX	No	No
Pharmacia And Upjohn	CORTEF	hydrocortisone	INJECTABLE;INJECTION	009864-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	NEO-CORT-DOME	hydrocortisone; neomycin sulfate	CREAM;TOPICAL	050237-005	Jun 5, 1984		DISCN	No	No

EU/EMA Drug Approvals for HYDROCORTISONE

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

International Patents for HYDROCORTISONE

Country	Patent Number	Title	Estimated Expiration
Denmark	2978414
Denmark	2780003
South Africa	201507210	COMPOSITION COMPRISING HYDROCORTISONE

Supplementary Protection Certificates for HYDROCORTISONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026