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Generated: May 29, 2017

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Hydrocortisone butyrate - Generic Drug Details

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What are the generic sources for hydrocortisone butyrate and what is the scope of hydrocortisone butyrate patent protection?

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

There are sixty drug master file entries for hydrocortisone butyrate. Nine suppliers are listed for this compound.

Summary for Generic Name: hydrocortisone butyrate

Drug Master File Entries: see list60
Suppliers / Packagers: see list9
Bulk Api Vendors: see list49
Clinical Trials: see list125
Patent Applications: see list3,884
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydrocortisone butyrate at DailyMed

Pharmacology for Ingredient: hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 1997AB2RXYesYes► Subscribe► Subscribe
Precision Dermat
hydrocortisone butyrate
SOLUTION;TOPICAL019116-001Feb 25, 1987ATRXYesYes► Subscribe► Subscribe
hydrocortisone butyrate
OINTMENT;TOPICAL019106-001Jul 3, 1984DISCNNoNo► Subscribe► Subscribe
Taro Pharm Inds
hydrocortisone butyrate
CREAM;TOPICAL076654-001Aug 3, 2005AB1RXNoNo► Subscribe► Subscribe
hydrocortisone butyrate
OINTMENT;TOPICAL076842-001Dec 27, 2004ABRXNoNo► Subscribe► Subscribe
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