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Last Updated: March 28, 2024

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, The J Molner, and Taro, and is included in fifteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for hydrocortisone butyrate. Six 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
PfizerPhase 4
Peking Union Medical College HospitalPhase 4
AllerdermPhase 4

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Pharmacology for hydrocortisone butyrate
Paragraph IV (Patent) Challenges for HYDROCORTISONE BUTYRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOCOID Lotion hydrocortisone butyrate 0.10% 022076 1 2016-08-31
LOCOID LIPOCREAM Cream hydrocortisone butyrate 0.10% 020769 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654-001 Aug 3, 2005 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145-001 Sep 27, 2013 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yamanouchi LOCOID hydrocortisone butyrate CREAM;TOPICAL 018795-001 Jan 7, 1983 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
The J Molner HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 209556-001 Nov 21, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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