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

Summary for Generic Name: hydrocortisone butyrate

Tradenames:3
Patents:2
Applicants:5
NDAs:12
Drug Master File Entries: see list50
Suppliers: see list8
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

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: 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

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

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
Status: Completed Condition: Primary Adrenal Insufficiency

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yamanouchi
LOCOID
hydrocortisone butyrate
OINTMENT;TOPICAL019106-001Jul 3, 1984DISCNNo<disabled><disabled>
Yamanouchi
LOCOID
hydrocortisone butyrate
CREAM;TOPICAL018795-001Jan 7, 1983DISCNNo<disabled><disabled>
Taro Pharm Inds
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
SOLUTION;TOPICAL076364-001Jan 14, 2004RXNo<disabled><disabled>
Taro Pharm Inds
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
CREAM;TOPICAL076654-001Aug 3, 2005RXNo<disabled><disabled>
Glenmark Generics
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
CREAM;TOPICAL202145-001Sep 27, 2013RXNo<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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