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Last Updated: June 20, 2024

HYDROCORTISONE Drug Patent Profile


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When do Hydrocortisone patents expire, and what generic alternatives are available?

Hydrocortisone is a drug marketed by 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, Teva Pharms, Fougera Pharms, Mericon, Paddock Llc, 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, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Encube Ethicals, and Padagis Israel. and is included in one hundred and thirty-two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydrocortisone

A generic version of HYDROCORTISONE was approved as hydrocortisone valerate by TARO on August 25th, 1998.

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Drug patent expirations by year for HYDROCORTISONE
Drug Prices for HYDROCORTISONE

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Drug Sales Revenue Trends for HYDROCORTISONE

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Recent Clinical Trials for HYDROCORTISONE

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SponsorPhase
University of North Carolina, Chapel HillPhase 4
Institute of Liver and Biliary Sciences, IndiaN/A
PilloxaN/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
Aurobindo Pharma Ltd HYDROCORTISONE hydrocortisone TABLET;ORAL 214649-003 Jul 17, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs HYDROCORTISONE hydrocortisone TABLET;ORAL 080355-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alpharma Us Pharms HYDROCORTISONE hydrocortisone LOTION;TOPICAL 087315-001 Jun 7, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva HYDROCORTISONE hydrocortisone CREAM;TOPICAL 080400-003 Approved Prior to Jan 1, 1982 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

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

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