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Last Updated: August 12, 2020

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Hydrocortisone butyrate - Generic Drug Details

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What are the generic drug sources for hydrocortisone butyrate and what is the scope of freedom to operate?

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerdermPhase 4
Wake Forest UniversityPhase 4

See all hydrocortisone butyrate clinical trials

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
Precision Dermat LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769-001 Sep 8, 1997 AB2 RX Yes Yes   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 205134-001 Dec 8, 2017 AB2 RX No No   Start Trial   Start Trial   Start Trial
Bausch LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076-001 May 18, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076-001 May 18, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teligent Pharma Inc HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 209556-001 Nov 21, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Precision Dermat LOCOID hydrocortisone butyrate OINTMENT;TOPICAL 018652-001 Oct 29, 1982 AB RX Yes Yes   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:

Colorcon
Johnson and Johnson
Boehringer Ingelheim
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Medtronic
Merck

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