GELNIQUE 3% Drug Patent Profile

When do Gelnique 3% patents expire, and when can generic versions of Gelnique 3% launch?

Gelnique 3% is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in GELNIQUE 3% is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for GELNIQUE 3%

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	5
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GELNIQUE 3%
DailyMed Link:	GELNIQUE 3% at DailyMed

Recent Clinical Trials for GELNIQUE 3%

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
Academic and Community Cancer Research United	Phase 3
University of Colorado, Denver	N/A

See all GELNIQUE 3% clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GELNIQUE 3%

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for GELNIQUE 3%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No

Expired US Patents for GELNIQUE 3%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011

EU/EMA Drug Approvals for GELNIQUE 3%

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Kentera (previously Oxybutynin Nicobrand)	oxybutynin	EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.	Authorised	no	no	no	2004-06-15

International Patents for GELNIQUE 3%

See the table below for patents covering GELNIQUE 3% around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1323430	Composition pour l' administration percutanée et/ou par voie transmucosale de principes actifs assurant des niveaux d'efficacité thérapeutiques adéquats (Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels)
European Patent Office	2612629	Compositions destines a la therapie par oxybutynine transdermique (Compositions for transdermal oxybutynin therapy)
World Intellectual Property Organization (WIPO)	0211768
New Zealand	541854	Uses and formulations for transdermal or transmucosal application of active agents
Israel	170454	תכשירים של חומרים פעילים למתן דרך העור או דרך ריריות ושימושים בהם (Transdermal or transmucosal formulations of active agents and uses thereof)