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LOCOID Drug Profile

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

Locoid is a drug marketed by Precision Dermat and Yamanouchi and is included in eight NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

Summary for LOCOID

US Patents:	2
Applicants:	2
NDAs:	8
Suppliers / Packagers:	4
Bulk Api Vendors:	52
Clinical Trials:	4
Patent Applications:	2,678
Formulation / Manufacturing:	see details
DailyMed Link:	LOCOID at DailyMed

Pharmacology for LOCOID

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for LOCOID

(11beta)-11,21-Dihydroxy-17-(1-oxobutoxy)pregn-4-ene-3,20-dione

(1S,10S,11S,15S,17S,2R,14R)-17-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl-5-ox otetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-14-yl butanoate

(1S,2R,10S,11S,14R,15S,17S)-17-HYDROXY-14-(2-HYDROXYACETYL)-2,15-DIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-14-YL BUTANOATE

[(8S,9S,10R,11S,13S,14S,17R)-10,13-dimethyl-11-oxidanyl-17-(2-oxidanylethanoyl)-3-oxidanylidene-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate

[(8S,9S,10R,11S,13S,14S,17R)-11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate

[11-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] butanoate

05RMF7YPWN

11-beta,17-alpha,21-Trihydroxy-4-pregnene-3,20-dione 17-alpha-butyrate

11-beta,17-alpha,21-trihydroxy-4-pregnene-3,20-dione17-alpha-butyrate

11|A,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate

11b,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate

11beta,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate

11beta,21-dihydroxy-17alpha-butyryloxy-4-pregnene-3,20-dione

11beta,21-dihydroxy-3,20-dioxopregn-4-en-17-yl butanoate

135467-84-4

13609-67-1

17-O-butyrylcortisol

4CA-0622

609H671

A807026

AB00052341_02

AC-492

AC1L1AHF

AC1L1GE2

ACMC-20mvrv

AJ-47560

AKOS015895443

Alfason

AN-15773

API0005043

AX8134121

BC214764

BSPBio_003158

Bucort

butanoic acid [(8S,9S,10R,11S,13S,14S,17R)-11-hydroxy-17-(2-hydroxy-1-oxoethyl)-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] ester

Butyric acid hydrocortisone

CAS-13609-67-1

CCG-39923

CHEBI:31674

CHEMBL1434261

CHEMBL1683

Cortisol 17-butyrate

CORTISOL, 17-BUTYRATE

CS-4474

CTK0H7965

D01619

DivK1c_000743

DSSTox_CID_25896

DSSTox_GSID_45896

DSSTox_RID_81208

DTXSID4045896

EINECS 237-093-4

Epitope ID:119710

H-17-B

H.17B

HB(sub 17)

hb(sub17)

HMS1922O17

HMS2093C09

HMS2231B16

HMS502F05

HY-B0983

Hycortate

Hydrocortisone 17-butyrate

Hydrocortisone 17alpha-butyrate

hydrocortisone butyrate

Hydrocortisone Butyrate (Hydrocortisone 17-Butyrate)

Hydrocortisone butyrate (JP17/USP)

Hydrocortisone butyrate [USAN:BAN:JAN]

Hydrocortisone butyrate [USAN:USP:BAN:JAN]

Hydrocortisone butyrate, United States Pharmacopeia (USP) Reference Standard

Hydrocortisone-17-butyrate

Hydrocortisone-17alpha-butyrate

I06-0576

IDI1_000743

KBio1_000743

KBio2_002131

KBio2_004699

KBio2_007267

KBio3_002658

KBioGR_001042

KBioSS_002131

Lacoid

Lacoidon

Laticort

locoid (TN)

LS-54996

LT00244772

MCULE-5041290339

MFCD00083364

MLS000028716

MLS001076086

MLS002207122

MolPort-003-941-574

NCGC00095037-01

NCGC00159427-02

NCGC00178233-01

NCGC00274077-01

NINDS_000743

NSC-758433

NSC758433

Opera_ID_188

Pharmakon1600-01503273

PL000382

Pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-(1-oxobutoxy)-, (11-beta)-

Pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-(1-oxobutoxy)-, (11beta)-

SBI-0051808.P002

SCHEMBL14936050

SCHEMBL4695

SMR000058859

SPBio_001212

Spectrum_001651

SPECTRUM1503273

Spectrum2_001106

Spectrum3_001589

Spectrum4_000581

Spectrum5_001171

ST075194

Tox21_111397

Tox21_111397_1

UNII-05RMF7YPWN

VA11057

W-108252

ZINC34779372

ZINC3977794

US Patents and Regulatory Information for LOCOID

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	hydrocortisone butyrate	CREAM;TOPICAL	018514-001	Mar 31, 1982	AB1	RX	Yes	Yes
Precision Dermat	LOCOID	hydrocortisone butyrate	SOLUTION;TOPICAL	019116-001	Feb 25, 1987	AT	RX	Yes	Yes
Precision Dermat	LOCOID	hydrocortisone butyrate	LOTION;TOPICAL	022076-001	May 18, 2007	AB	RX	Yes	Yes			Y
Yamanouchi	LOCOID	hydrocortisone butyrate	SOLUTION;TOPICAL	019819-001	Sep 15, 1988		DISCN	No	No

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Paragraph IV (Patent) Challenges for LOCOID

Drugname	Dosage	Strength	RLD	Submissiondate
	Lotion	0.1%		2016-08-31
	Cream	0.1%		2010-06-28

Premature patent expiration for: LOCOID

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	LOCOID

Non-Orange Book US Patents for LOCOID

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,389,502	Stabilized steroid composition and method for its preparation
8,546,364	Stabilized steroid composition and method for its preparation

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