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Last Updated: July 2, 2020

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GELNIQUE Drug Profile


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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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in twenty 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.

US ANDA Litigation and 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

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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
University of Colorado, DenverN/A
Society for Pediatric DermatologyN/A
Astellas Scientific & Medical Affairs, Inc.N/A

See all GELNIQUE clinical trials

Pharmacology for GELNIQUE
Paragraph IV (Patent) Challenges for GELNIQUE
Tradename Dosage Ingredient NDA Submissiondate
GELNIQUE GEL;TRANSDERMAL oxybutynin chloride 022204 2014-06-19

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan GELNIQUE 3% oxybutynin GEL, METERED;TRANSDERMAL 202513-001 Dec 7, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 RX Yes Yes   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

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Medtronic
Colorcon
Merck
Harvard Business School

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