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Last Updated: October 28, 2021

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HYDROCORTISONE BUTYRATE Drug Patent Profile


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When do Hydrocortisone Butyrate patents expire, and what generic alternatives are available?

Hydrocortisone Butyrate is a drug marketed by Actavis Mid Atlantic, Glenmark Generics, Taro Pharm Inds, Lupin Ltd, Teligent, and Taro. and is included in seven NDAs.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydrocortisone Butyrate

A generic version of HYDROCORTISONE BUTYRATE was approved as hydrocortisone butyrate by TARO PHARM INDS on January 14th, 2004.

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Drug patent expirations by year for HYDROCORTISONE BUTYRATE
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
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE BUTYRATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
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
Actavis Mid Atlantic HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 205134-001 Dec 8, 2017 AB2 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate SOLUTION;TOPICAL 076364-001 Jan 14, 2004 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 210209-001 Aug 17, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Generics HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145-001 Sep 27, 2013 AB2 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654-001 Aug 3, 2005 AB1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro HYDROCORTISONE BUTYRATE hydrocortisone butyrate OINTMENT;TOPICAL 076842-001 Dec 27, 2004 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teligent HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 209556-001 Nov 21, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Baxter
McKinsey
McKesson
Moodys
Johnson and Johnson
Dow

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