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Last Updated: April 24, 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
Drug Prices for GELNIQUE

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Drug Sales Revenue Trends 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
Society for Pediatric DermatologyN/A

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan GELNIQUE 3% oxybutynin GEL, METERED;TRANSDERMAL 202513-001 Dec 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
>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
Japan 5770582 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2010129498 ⤷  Try a Trial
European Patent Office 3659562 COMPOSITIONS DESTINES A LA THERAPIE PAR OXYBUTYNINE TRANSDERMIQUE (COMPOSITIONS FOR TRANSDERMAL OXYBUTYNIN THERAPY) ⤷  Try a Trial
Canada 2821174 PROCEDE DE TRAITEMENT DE VESSIES HYPERACTIVES ET DISPOSITIF DE STOCKAGE ET D'ADMINISTRATION DE COMPOSITIONS TOPIQUES D'OXYBUTYNINE (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.