NUTRACORT Drug Patent Profile

Name: NUTRACORT Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 is one drug master file entry for this compound. Forty-two 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 30^th, 2007.

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Summary for NUTRACORT

US Patents:	0
Applicants:	3
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	8
Patent Applications:	5,027
DailyMed Link:	NUTRACORT at DailyMed

Drug patent expirations by year for NUTRACORT

Recent Clinical Trials for NUTRACORT

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Children's Oncology Group	Phase 1
EsPhALL network I-BFM Study Group	Phase 3

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US Patents and Regulatory Information for NUTRACORT

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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
Bausch	NUTRACORT	hydrocortisone	CREAM;TOPICAL	080442-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Dow Pharm	NUTRACORT	hydrocortisone	LOTION;TOPICAL	080443-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bausch	NUTRACORT	hydrocortisone	CREAM;TOPICAL	080442-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Healthpoint	NUTRACORT	hydrocortisone	GEL;TOPICAL	084698-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start 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

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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/002185Treatment of adrenal insufficiency in adults.	Authorised	no	no	no	2011-11-03
Diurnal Europe B.V.	Alkindi	hydrocortisone	EMEA/H/C/004416Replacement 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/005105Treatment 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

Last updated: July 9, 2026

NUTRACORT market dynamics and financial trajectory: sales drivers, revenue trend, exclusivity timeline, and generic risk

NUTRACORT’s market trajectory is defined by a narrow commercial footprint, pricing pressure from local competitors and generics, and lifecycle risk concentrated in (1) formulation and method-of-use exclusivity, (2) OTC-to-Rx adjacency dynamics where applicable, and (3) regional approval status that determines when generic entry becomes legally and operationally feasible. A reliable financial trajectory analysis requires verified product scope (strength, dosage form), geography (US vs EU vs LATAM vs MENA), and current sales reporting. No such NUTRACORT-specific dataset is provided in the prompt, and an NUTRACORT-to-ingredient mapping is not supplied. Under the operating constraints, a complete and accurate market and financial trajectory cannot be produced.

What is NUTRACORT and how is it marketed in the current market?

Featured snippet answer: Insufficient verified product identity details to define the drug, active ingredient(s), strength, dosage form, and labeled indication set. Without those, market characterization and financial modeling cannot be made.