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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 three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for hydrocortisone butyrate. Eight suppliers are listed for this compound.

Summary for Generic Name: hydrocortisone butyrate

Drug Master File Entries: see list50
Suppliers: see list8
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for Ingredient: hydrocortisone butyrate

Clinical Trials for: hydrocortisone butyrate

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

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease
Status: Not yet recruiting Condition: Addison Disease

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

Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
Status: Enrolling by invitation Condition: Adrenal Insufficiency

An Investigational Study of Hydrocortisone
Status: Completed Condition: Adrenal Insufficiency

Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)
Status: Completed Condition: Adrenal Insufficiency

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
hydrocortisone butyrate
CREAM;TOPICAL018795Jan 7, 1983DISCNNo<disabled><disabled>
Precision Dermat
hydrocortisone butyrate
LOTION;TOPICAL022076May 18, 2007RXYes7,378,405<disabled>Y<disabled>
Precision Dermat
hydrocortisone butyrate
LOTION;TOPICAL022076May 18, 2007RXYes7,981,877<disabled>Y<disabled>
Glenmark Generics
hydrocortisone butyrate
CREAM;TOPICAL202145Sep 27, 2013RXNo<disabled><disabled>
Precision Dermat
hydrocortisone butyrate
CREAM;TOPICAL020769Sep 8, 1997RXYes5,635,497<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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