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Last Updated: January 23, 2020

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GELNIQUE 3% Drug Profile

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When do Gelnique 3% patents expire, and what generic alternatives are available?

Gelnique 3% is a drug marketed by Allergan and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-two countries.

The generic ingredient in GELNIQUE 3% is oxybutynin. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxybutynin profile page.

US ANDA Litigation and Generic Entry Outlook for Gelnique 3%

Gelnique 3% was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Drug patent expirations by year for GELNIQUE 3%
Recent Clinical Trials for GELNIQUE 3%

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

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

See all GELNIQUE 3% clinical trials

Recent Litigation for GELNIQUE 3%

Identify potential future generic entrants

District Court Litigation
Case NameDate
Auxilium Pharmaceuticals v. Upsher-Smith Laboratories2014-01-29

See all GELNIQUE 3% litigation

US Patents and Regulatory Information for GELNIQUE 3%

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
AstraZeneca
Medtronic
McKinsey
Colorcon

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