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 Pharms Ltd, 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.

Summary for hydrocortisone butyrate

US Patents:	1
Tradenames:	3
Applicants:	9
NDAs:	15
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	4
Patent Applications:	6,799
Drug Prices:	Drug price trends for hydrocortisone butyrate
What excipients (inactive ingredients) are in hydrocortisone butyrate?	hydrocortisone butyrate excipients list
DailyMed Link:	hydrocortisone butyrate at DailyMed

See drug prices for hydrocortisone butyrate

Recent Clinical Trials for hydrocortisone butyrate

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

Sponsor	Phase
Pfizer	Phase 4
Peking Union Medical College Hospital	Phase 4
Allerderm	Phase 4

See all hydrocortisone butyrate clinical trials

Pharmacology for hydrocortisone butyrate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	OINTMENT;TOPICAL	076842-001	Dec 27, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	LOCOID	hydrocortisone butyrate	LOTION;TOPICAL	022076-001	May 18, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Precision Dermat	LOCOID LIPOCREAM	hydrocortisone butyrate	CREAM;TOPICAL	020769-001	Sep 8, 1997	AB2	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The J Molner	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	LOTION;TOPICAL	209556-001	Nov 21, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	CREAM;TOPICAL	202145-001	Sep 27, 2013	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro Pharm Inds	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	CREAM;TOPICAL	076654-001	Aug 3, 2005	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for hydrocortisone butyrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Precision Dermat	LOCOID LIPOCREAM	hydrocortisone butyrate	CREAM;TOPICAL	020769-001	Sep 8, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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