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Last Updated: November 2, 2024

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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Drug patent expirations by year for GELNIQUE
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Recent Clinical Trials for GELNIQUE

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SponsorPhase
National Cancer Institute (NCI)Phase 3
Academic and Community Cancer Research UnitedPhase 3
University of Colorado, DenverN/A

See all GELNIQUE clinical trials

Pharmacology for GELNIQUE
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

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

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

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.

Country Patent Number Title Estimated Expiration
Australia 2010246103 A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions ⤷  Sign Up
Canada 2406064 REDUCTION D'EPISODES INDESIRABLES ASSOCIES A UNE THERAPIE PAR L'OXYBUTYNINE (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY) ⤷  Sign Up
Canada 2504021 COMPOSITIONS ET PROCEDES DESTINES A LA THERAPIE PAR OXYBUTYNINE TRANSDERMIQUE (COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY) ⤷  Sign Up
European Patent Office 1565136 COMPOSITIONS DESTINES A LA THERAPIE PAR OXYBUTYNINE TRANSDERMIQUE (COMPOSITIONS FOR TRANSDERMAL OXYBUTYNIN THERAPY) ⤷  Sign Up
European Patent Office 2322170 Minimisation d'expérience indésirable associée à la thérapie oxybutynine (Minimizing adverse experience associated with oxybutynin therapy) ⤷  Sign Up
China 102327253 Minimizing adverse experience associated with oxybutynin therapy ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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