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Last Updated: March 28, 2024

NUTRACORT Drug Patent Profile


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

Nutracort is a drug marketed by Bausch, Healthpoint, and Dow Pharm. and is included in four NDAs.

The generic ingredient in NUTRACORT 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 Nutracort

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

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

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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 NUTRACORT clinical trials

US Patents and Regulatory Information for NUTRACORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch NUTRACORT hydrocortisone CREAM;TOPICAL 080442-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dow Pharm NUTRACORT hydrocortisone LOTION;TOPICAL 080443-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch NUTRACORT hydrocortisone CREAM;TOPICAL 080442-003 Approved Prior to Jan 1, 1982 DISCN No 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 NUTRACORT

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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