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Details for Generic Name: hydrocortisone butyrate

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Hydrocortisone butyrate is the generic ingredient in three branded drugs marketed by Glenmark Generics, Taro Pharm Inds, Precision Dermat, Yamanouchi, and Taro, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifty-one drug master file entries for hydrocortisone butyrate. Seven suppliers are listed for this compound.

Summary for Generic Name: hydrocortisone butyrate

Drug Master File Entries: see list51
Suppliers / Packaging: see list21
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for Ingredient: hydrocortisone butyrate

Clinical Trials for: hydrocortisone butyrate

The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism
Status: Recruiting Condition: Hypopituitarism; Hydrocortisone; Lipids; Fatty Acids, Nonesterified; Insulin Sensitivity

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia
Status: Active, not recruiting Condition: Addison Disease; Adrenal Hyperplasia Congenital

Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
Status: Completed Condition: Congenital Adrenal Hyperplasia; 21-Hydroxylase Deficiency; Adrenogenital Syndrome

Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
Status: Completed Condition: Adrenal Insufficiency

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration
Status: Completed Condition: Major Depressive Disorder; Anxiety Disorders

Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
Status: Completed Condition: Healthy

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat
hydrocortisone butyrate
LOTION;TOPICAL022076-001May 18, 2007RXYes7,378,405<disabled>Y <disabled>
Taro Pharm Inds
hydrocortisone butyrate
CREAM;TOPICAL076654-001Aug 3, 2005RXNo<disabled><disabled>
Precision Dermat
hydrocortisone butyrate
CREAM;TOPICAL018514-001Mar 31, 1982RXYes<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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