GELNIQUE Drug Patent Profile

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

Gelnique is a drug marketed by Allergan and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in thirteen countries.

The generic ingredient in GELNIQUE 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.

DrugPatentWatch^® Generic Entry Outlook for Gelnique

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for GELNIQUE

International Patents:	21
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	5
Patent Applications:	1,620
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GELNIQUE
What excipients (inactive ingredients) are in GELNIQUE?	GELNIQUE excipients list
DailyMed Link:	GELNIQUE at DailyMed

See drug prices for GELNIQUE

See drug sales revenues for GELNIQUE

Recent Clinical Trials for GELNIQUE

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 clinical trials

Pharmacology for GELNIQUE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for GELNIQUE

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

Paragraph IV (Patent) Challenges for GELNIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GELNIQUE	Gel	oxybutynin chloride	10%	022204	1	2014-06-19

US Patents and Regulatory Information for GELNIQUE

GELNIQUE is protected by three US patents.

Patents protecting GELNIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		RX	Yes	Yes
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No			Y
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		RX	Yes	Yes			Y
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		RX	Yes	Yes

Expired US Patents for GELNIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009

International Patents for GELNIQUE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2011011642	UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.)
Brazil	0110381	Minimizando experiência adversa associada com terapia com oxibutinina
Canada	2504021	COMPOSITIONS ET PROCEDES DESTINES A LA THERAPIE PAR OXYBUTYNINE TRANSDERMIQUE (COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY)
World Intellectual Property Organization (WIPO)	2010129498
Japan	2017008085	オキシブチニン治療に関連した有害な経験の最小化 (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY)
European Patent Office	1992342	Minimisation d'expérience indésirable associée à la thérapie oxybutynine (Minimizing adverse experience associated with oxybutynin therapy)