GELNIQUE Drug Patent Profile

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

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

This drug has twenty-two 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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for GELNIQUE

International Patents:	22
US Patents:	3
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Patent Applications:	1,693
Drug Prices:	Drug price information for GELNIQUE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GELNIQUE
What excipients (inactive ingredients) are in GELNIQUE?	GELNIQUE excipients list
DailyMed Link:	GELNIQUE at DailyMed

Drug patent expirations by year for GELNIQUE

Recent Clinical Trials for GELNIQUE

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

Sponsor	Phase
Academic and Community Cancer Research United	Phase 3
National Cancer Institute (NCI)	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

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

Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE WITH A SINGLE UNIT DOSE OF 10% OXYBUTYNIN CHLORIDE GEL

Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN

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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
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for GELNIQUE

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

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Country	Patent Number	Title	Estimated Expiration
Spain	2764081		⤷ Sign Up
Hong Kong	1052287	MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY	⤷ Sign Up
Spain	2532495		⤷ Sign Up
Japan	6209263		⤷ Sign Up
Australia	2012216593	Compositions and methods for transdermal oxybutynin therapy	⤷ Sign Up
Japan	2015131826	経皮オキシブチニン療法のための組成物および方法 (COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY)	⤷ Sign Up
Norway	343756		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration