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DESONATE Drug Profile

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When do Desonate patents expire, and when can generic versions of Desonate launch?

Desonate is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twenty-two countries.

The generic ingredient in DESONATE is desonide. There are thirty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

Summary for DESONATE

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	35
Clinical Trials:	1
Patent Applications:	4,049
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESONATE
DailyMed Link:	DESONATE at DailyMed

Pharmacology for DESONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for DESONATE

Anti-Inflammatory Agents

Synonyms for DESONATE

(11ss,16alpha)-11,21-Dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione

(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.0;{2,9}.0;{4,8}.0;{13,18}]icosa-14,17-dien-16-one

(4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one

11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone

11beta,21-dihydroxy-16alpha,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione

11beta,21-dihydroxy-16alpha,17-isopropylidenedioxypregna-1,4-diene-3,20-dione

11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione

16-alpha-Hydroxyprednisole-16,17-acetonide

16?,17-[1-Methylethylidenebis(oxy)]-11?,21-dihydroxypregna-1,4-diene-3,20-dione

16alpha-hydroxyprednisole-16,17-acetonide

16alpha-hydroxyprednisolone-16alpha,17-acetonide

16alpha,17-[1-Methylethylidenebis(oxy)]-11beta,21-dihydroxypregna-1,4-diene-3,20-dione (Desonide)

16alpha,17alpha-isopropylidenedioxyprednisolone

638-94-8

638D948

AB01274712_02

AB01274712-01

AB2000229

Apolar

AS-13892

budesonide acetonide

C-22009

CAS-638-94-8

CC-26356

CCG-221279

CHEBI:204734

CHEMBL1201109

CS-2228

D 2083

D-2083

D02JNM

D03696

D2083

DB01260

desfluorotriamcinolone acetonide

Desilux

Desonida

Desonida [INN-Spanish]

DESONIDE

Desonide (USAN/INN)

Desonide [USAN:INN:BAN]

Desonidum

Desonidum [INN-Latin]

DesOwen

Desowen (TN)

DSSTox_CID_26756

DSSTox_GSID_46756

DSSTox_RID_81880

DTXSID7046756

EINECS 211-351-6

Flusemidon

GTPL7066

Hamiltoderm

HY-B0248

J280872D1O

K016

Locapred

Locapred, Topifug, Tridesilon, Desonide

Locapred;Topifug;Tridesilon

MolPort-003-987-087

NCGC00167983-01

NCGC00274065-01

Prednacinolone

Prednisolone-16,17-acetonide, 16-alpha-hydroxy-

Pregna-1,4-diene-3,20-dione, 11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-

Prenacid

Q-101382

Reticus

s1701

SC-17104

SCHEMBL3631

Sterax

Steroderm

TL8004516

Topifug

Tox21_112603

Tox21_112603_1

Tridesilon

Tridesonit

UNII-J280872D1O

Verdeso

Verdeso (TN)

Verdeso Foam (TN)

WBGKWQHBNHJJPZ-LECWWXJVSA-N

ZINC4212851

Zotinar

US Patents and Regulatory Information for DESONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006		RX	Yes	Yes			Y	Y

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Paragraph IV (Patent) Challenges for DESONATE

Drugname	Dosage	Strength	RLD	Submissiondate
	Gel	0.05%		2010-12-01

Non-Orange Book US Patents for DESONATE

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
6,517,847	Topical gel delivery system

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International Patents for DESONATE

Country	Document Number	Estimated Expiration
Portugal	2052714
Canada	2417646
Poland	360589
China	101305982

Supplementary Protection Certificates for DESONATE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
00617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322