DESONATE Drug Patent Profile

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

Desonate is a drug marketed by Leo Pharma As and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Desonate

A generic version of DESONATE was approved as desonide by TARO on August 3^rd, 1994.

Summary for DESONATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Applications:	4,822
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DESONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESONATE
What excipients (inactive ingredients) are in DESONATE?	DESONATE excipients list
DailyMed Link:	DESONATE at DailyMed

See drug prices for DESONATE

See drug sales revenues for DESONATE

Recent Clinical Trials for DESONATE

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

Sponsor	Phase
Wake Forest University	Phase 4

See all DESONATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DESONATE

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DESONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESONATE	Gel	desonide	0.05%	021844	1	2010-12-01

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
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006		DISCN	Yes	No

Expired US Patents for DESONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006

International Patents for DESONATE

See the table below for patents covering DESONATE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2001279002
Brazil	0113247
Denmark	1304992
South Korea	20080036246
Russian Federation	2251410	СИСТЕМА ДОСТАВКИ В ВИДЕ ГЕЛЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ (DELIVERY SYSTEM IN THE FORM OF GEL FOR LOCAL APPLICATION)
Mexico	PA03001006	SISTEMA DE SUMINISTRO LOCAL DE GEL. (TOPICAL GEL DELIVERY SYSTEM.)

Supplementary Protection Certificates for DESONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025	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	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
1304992	C300617	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
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718