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.
|Drug Master File Entries: see list||50|
|Suppliers: see list||8|
|Therapeutic Class:||Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|CREAM;TOPICAL||018795||Jan 7, 1983||DISCN||No||<disabled>||<disabled>|
|LOTION;TOPICAL||022076||May 18, 2007||RX||Yes||7,378,405||<disabled>||Y||<disabled>|
|LOTION;TOPICAL||022076||May 18, 2007||RX||Yes||7,981,877||<disabled>||Y||<disabled>|
|CREAM;TOPICAL||202145||Sep 27, 2013||RX||No||<disabled>||<disabled>|
|CREAM;TOPICAL||020769||Sep 8, 1997||RX||Yes||5,635,497||<disabled>||<disabled>|
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