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 is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

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Summary for GELNIQUE 3%

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	5
DailyMed Link:	GELNIQUE 3% at DailyMed

Drug patent expirations by year for GELNIQUE 3%

Recent Clinical Trials for GELNIQUE 3%

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Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
Academic and Community Cancer Research United	Phase 3
Society for Pediatric Dermatology	N/A

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US Patents and Regulatory Information for GELNIQUE 3%

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Glossary

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for GELNIQUE 3%

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011	7,029,694	⤷ Start Trial
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011	8,241,662	⤷ Start Trial
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011	7,198,801	⤷ Start Trial
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011	7,179,483	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for GELNIQUE 3%

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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/000532Symptomatic 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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for GELNIQUE 3%

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

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Country	Patent Number	Title	Estimated Expiration
Austria	488233		⤷ Start Trial
Australia	2001253782		⤷ Start Trial
Australia	2003287377	COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY	⤷ Start Trial
Australia	2003294239	COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY	⤷ Start Trial
Australia	2010200418	Compositions and methods for transdermal oxybutynin therapy	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for GELNIQUE 3%

Recent Clinical Trials for GELNIQUE 3%

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