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Desoximetasone - Generic Drug Details

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What are the generic drug sources for desoximetasone and what is the scope of desoximetasone freedom to operate?

Desoximetasone is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Akorn, Fougera Pharms, Groupe Parima Inc, Lupin Atlantis, Perrigo New York, Taro Pharm Inds Ltd, Rising Pharms Inc, Altana, G And W Labs Inc, Glenmark Generics, Novel Labs Inc, Perrigo Israel, Teligent Pharma Inc, Zydus Pharms Usa Inc, and Taro Pharms, and is included in thirty-six NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Desoximetasone has four patent family members in four countries.

There are seven drug master file entries for desoximetasone. Eighteen suppliers are listed for this compound.

Summary for desoximetasone

International Patents:	4
US Patents:	3
Tradenames:	3
Applicants:	16
NDAs:	36
Drug Master File Entries:	7
Suppliers / Packagers:	18
Bulk Api Vendors:	36
Clinical Trials:	8
Patent Applications:	6,065
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for desoximetasone
DailyMed Link:	desoximetasone at DailyMed

Pharmacology for desoximetasone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for desoximetasone

Anti-Inflammatory Agents

Glucocorticoids

Synonyms for desoximetasone

(11beta,16alpha)-9-Fluoro-11,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione

(1R,2S,10S,11S,13R,14S,15S,17S)-1-fluoro-17-hydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-5-one

(8S,9R,10S,11S,13S,14S,16R,17S)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-7,8,11,12,14,15,16,17-octahydro-6H-cyclopenta[a]phenanthren-3-one

17-Deoxymethansone

17-Desoximethasone

382-67-2

382D672

4E07GXB7AU

9-Fluoro-11-beta,21-dihydroxy-16-alpha-methylpregna-1,4-diene-3,20-dione

9-Fluoro-11beta,21-dihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione

9alpha-fluoro-11beta,21-dihydroxy-16alpha-methyl-1.4-pregnadiene-3,20-dione

9alpha-fluoro-16alpha-methyl-Delta(1)-corticosterone

A 41-304

A 41304

A-41-304

AB2000738

AC1NSJXQ

AKOS030254657

AS-15787

BDBM50103622

BRN 2228097

C-55186

CAS-382-67-2

CCG-101120

CHEBI:691037

CHEMBL1766

CS-3002

CTK8F9086

D03697

D0CZ1Q

DB00547

Deoxymethasone

Desossimetasone

Desossimetasone [DCIT]

Desoximetason

Desoximetasona

Desoximetasona [INN-Spanish]

Desoximetasone (USP/INN)

Desoximetasone [USAN:USP:INN:BAN]

Desoximetasonum

Desoximetasonum [INN-Latin]

desoximethasone

Desoxymetasone

Desoxymethasone

DSSTox_CID_25647

DSSTox_GSID_45647

DSSTox_RID_81025

DTXSID3045647

EINECS 206-845-3

Esperson

Flubason

GTPL7067

HMS2052C15

HMS2236H07

HOE 304

HOE-304

HY-17570

Ibaril

MLS000028654

MLS001076073

MLS001424230

MolPort-003-941-111

NC00370

NCGC00023648-03

NCGC00023648-04

Opera_ID_52

Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16-methyl-, (11beta,16alpha)-

Q-200938

Q790

R 2113

R-2113

SC-46986

SCHEMBL4214

SMR000058856

Stiedex

Topicort

Topicort (TN)

Topicort Emollient (TN)

Topicort LP

Topisolon

Tox21_110889

Tox21_110889_1

UNII-4E07GXB7AU

VWVSBHGCDBMOOT-IIEHVVJPSA-N

ZINC4212854

US Patents and Regulatory Information for desoximetasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akorn	DESOXIMETASONE	desoximetasone	CREAM;TOPICAL	203787-001	Jan 6, 2017	AB	RX	No	No
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018763-001	Sep 30, 1983		DISCN	Yes	No
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	OINTMENT;TOPICAL	074286-001	Jun 7, 1996	AB	RX	No	Yes
Taro Pharm Inds Ltd	TOPICORT	desoximetasone	CREAM;TOPICAL	017856-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

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Expired US Patents for desoximetasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro Pharms	TOPICORT	desoximetasone	SPRAY;TOPICAL	204141-001	Apr 11, 2013

Non-Orange Book US Patents for desoximetasone

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
5,886,038	Composition and method for treatment of psoriasis

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International Patents for desoximetasone

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006130510
Israel	187666
Canada	2609579
European Patent Office	1888026