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Last Updated: August 5, 2020

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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 patent protection?

Hydrocortisone butyrate is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Generics, Taro Pharm Inds, Bausch, Yamanouchi, Precision Dermat, Lupin Ltd, Teligent Pharma Inc, and Taro, and is included in fifteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixty-seven drug master file entries for hydrocortisone butyrate. Ten suppliers are listed for this compound.

Drug Prices for HYDROCORTISONE BUTYRATE

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Recent Clinical Trials for HYDROCORTISONE BUTYRATE

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SponsorPhase
AllerdermPhase 4
Wake Forest UniversityPhase 4

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Pharmacology for HYDROCORTISONE BUTYRATE
Paragraph IV (Patent) Challenges for HYDROCORTISONE BUTYRATE
Tradename Dosage Ingredient NDA Submissiondate
LOCOID LOTION;TOPICAL hydrocortisone butyrate 022076 2016-08-31
LOCOID LIPOCREAM CREAM;TOPICAL hydrocortisone butyrate 020769 2010-06-28

US Patents and Regulatory Information for HYDROCORTISONE BUTYRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Generics HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145-001 Sep 27, 2013 AB2 RX No No   Start Trial   Start Trial   Start Trial
Yamanouchi LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019819-001 Sep 15, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate SOLUTION;TOPICAL 076364-001 Jan 14, 2004 AT RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Merck
Baxter
AstraZeneca
Moodys

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