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GELNIQUE Drug Profile
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» See Plans and PricingWhen 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
Summary for GELNIQUE
| International Patents: | 84 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 3 |
| Patent Applications: | 1,517 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GELNIQUE |
| DailyMed Link: | GELNIQUE at DailyMed |
Recent Clinical Trials for GELNIQUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Colorado, Denver | N/A |
| Society for Pediatric Dermatology | N/A |
| Astellas Scientific & Medical Affairs, Inc. | N/A |
Pharmacology for GELNIQUE
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
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 |
International Patents for GELNIQUE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA02010542 | Start Trial |
| Australia | 2003294239 | Start Trial |
| Japan | 2015131826 | Start Trial |
| Norway | 339626 | Start Trial |
| Mexico | 367923 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
