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 Allergan and is included in two NDAs. There are four 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
Summary for GELNIQUE
| International Patents: | 22 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 107 |
| Clinical Trials: | 5 |
| Patent Applications: | 1,693 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GELNIQUE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GELNIQUE |
| What excipients (inactive ingredients) are in GELNIQUE? | GELNIQUE excipients list |
| DailyMed Link: | GELNIQUE at DailyMed |
Recent Clinical Trials for GELNIQUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 3 |
| Academic and Community Cancer Research United | Phase 3 |
| University of Colorado, Denver | N/A |
Pharmacology for GELNIQUE
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | RX | Yes | Yes | ⤷ 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 | Y | ⤷ Try a Trial | |||
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | RX | Yes | Yes | ⤷ 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 |
|---|---|---|---|---|---|---|---|
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | GELNIQUE | oxybutynin chloride | GEL;TRANSDERMAL | 022204-001 | Jan 27, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | 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 | 2012046526 | COMPOSITION AND METHOD FOR TRANSDERMAL OXYBUTYNIN THERAPY | ⤷ Try a Trial |
| Mexico | 342305 | MINIMIZACION DE EXPERIENCIAS ADVERSAS ASOCIADAS CON LA TERAPIA CON OXIBUTININA. (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY.) | ⤷ Try a Trial |
| Russian Federation | 2011144397 | СПОСОБ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ МОЧЕВОГО ПУЗЫРЯ И УСТРОЙСТВО ДЛЯ ХРАНЕНИЯ И ПРИМЕНЕНИЯ КОМПОЗИЦИИ ОКСИБУТИНИНА МЕСТНОГО ДЕЙСТВИЯ | ⤷ Try a Trial |
| Norway | 20052625 | ⤷ Try a Trial | |
| Mexico | 367923 | UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.) | ⤷ Try a Trial |
| Norway | 339626 | ⤷ 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.
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