➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Boehringer Ingelheim
McKesson
Medtronic
Merck

Last Updated: July 23, 2021

DrugPatentWatch Database Preview

Hydrocortisone butyrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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, 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. One supplier is listed for this compound.

Drug Prices for hydrocortisone butyrate

See drug prices for hydrocortisone butyrate

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
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
Yamanouchi LOCOID hydrocortisone butyrate OINTMENT;TOPICAL 019106-001 Jul 3, 1984 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lupin Ltd HYDROCORTISONE BUTYRATE hydrocortisone butyrate LOTION;TOPICAL 210209-001 Aug 17, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Yamanouchi LOCOID hydrocortisone butyrate CREAM;TOPICAL 018795-001 Jan 7, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch LOCOID hydrocortisone butyrate CREAM;TOPICAL 018514-001 Mar 31, 1982 AB1 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116-001 Feb 25, 1987 AT RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Generics HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145-001 Sep 27, 2013 AB2 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taro HYDROCORTISONE BUTYRATE hydrocortisone butyrate OINTMENT;TOPICAL 076842-001 Dec 27, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Boehringer Ingelheim
McKesson
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.