Hydrocortisone - Generic Drug Details

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What are the generic sources for hydrocortisone and what is the scope of patent protection?

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, Taro Pharm Inds Ltd, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Chartwell, Ani Pharms, Teva Pharms, Healthpoint, Eton, Pharmacia And Upjohn, Baker Norton, Derm Rx, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Pai Holdings Pharm, Dow Pharm, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Paddock Llc, Mission Pharma, Pfizer, 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, Akorn, Bel Mar, Fera Pharms, Colgate, Genus, Ferndale Labs, Glenmark Generics, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Cosette, Encube Ethicals, Glenmark Pharms Ltd, Padagis Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-four patent family members in twenty-four countries.

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

Summary for hydrocortisone

International Patents:	54
US Patents:	5
Tradenames:	76
Applicants:	113
NDAs:	257
Drug Master File Entries:	67
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	424
Patent Applications:	7,153
Formulation / Manufacturing:	see details
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

Drug Sales Revenue Trends for hydrocortisone

See drug sales revenues for hydrocortisone

Recent Clinical Trials for hydrocortisone

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

Sponsor	Phase
Montefiore Medical Center	N/A
Instituto do Cancer do Estado de São Paulo	N/A
Fundação Faculdade Regional de Medicina de São José do Rio Preto	N/A

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

US Patents and Regulatory Information for hydrocortisone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purepac Pharm	HYDROCORTISONE	hydrocortisone	TABLET;ORAL	084247-002	Approved Prior to Jan 1, 1982		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Strides Pharma	HYDROCORTISONE	hydrocortisone	TABLET;ORAL	040761-001	Jul 16, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Chartwell Molecular	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	040503-001	Mar 12, 2004		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 hydrocortisone

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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

International Patents for hydrocortisone

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Country	Patent Number	Title	Estimated Expiration
Mexico	2015015759	COMPOSICION QUE COMPRENDE HIDROCORTISONA. (COMPOSITION COMPRISING HYDROCORTISONE.)	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2014184525		See Plans and Pricing
Japan	6228125		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for hydrocortisone

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

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