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Last Updated: December 8, 2022

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.

Drug Prices for hydrocortisone

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Drug Sales Revenue Trends for hydrocortisone

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Recent Clinical Trials for hydrocortisone

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

Montefiore Medical CenterN/A
Instituto do Cancer do Estado de São PauloN/A
Fundação Faculdade Regional de Medicina de São José do Rio PretoN/A

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Pharmacology for hydrocortisone
Medical Subject Heading (MeSH) Categories for hydrocortisone

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
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

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

Supplementary Protection Certificates for hydrocortisone

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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