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Hydrocortisone butyrate - Generic Drug Details

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

There are fifty-three 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 list53
Suppliers / Packaging: see list8
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrocortisone butyrate

Clinical Trials for: hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat
LOCOID
hydrocortisone butyrate
OINTMENT;TOPICAL018652-001Oct 29, 1982RXYes<disabled><disabled>
Taro
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
OINTMENT;TOPICAL076842-001Dec 27, 2004RXNo<disabled><disabled>
Precision Dermat
LOCOID
hydrocortisone butyrate
CREAM;TOPICAL018514-001Mar 31, 1982RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: hydrocortisone butyrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Precision Dermat
LOCOID LIPOCREAM
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 19975,635,497<disabled>
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Non-Orange Book Patents for Generic Ingredient: hydrocortisone butyrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,546,364Stabilized steroid composition and method for its preparation<disabled in preview>
8,389,502Stabilized steroid composition and method for its preparation<disabled in preview>
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