GELNIQUE 3% Drug Patent Profile
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When do Gelnique 3% patents expire, and when can generic versions of Gelnique 3% launch?
Gelnique 3% is a drug marketed by Allergan and is included in one NDA.
The generic ingredient in GELNIQUE 3% 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.
Summary for GELNIQUE 3%
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GELNIQUE 3% |
| DailyMed Link: | GELNIQUE 3% at DailyMed |
Recent Clinical Trials for GELNIQUE 3%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Academic and Community Cancer Research United | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
| University of Colorado, Denver | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for GELNIQUE 3%
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 | ⤷ 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 3%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Allergan | GELNIQUE 3% | oxybutynin | GEL, METERED;TRANSDERMAL | 202513-001 | Dec 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for GELNIQUE 3%
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Teva B.V. | Kentera (previously Oxybutynin Nicobrand) | oxybutynin | EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder. |
Authorised | no | no | no | 2004-06-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for GELNIQUE 3%
See the table below for patents covering GELNIQUE 3% around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2538856 | FORMULATION PHARMACEUTIQUE TRANSDERMIQUE VISANT A REDUIRE LES RESIDUS SUR LA PEAU (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES) | ⤷ Try a Trial |
| Australia | 5378201 | Minimizing adverse experience associated with oxybutynin therapy | ⤷ Try a Trial |
| South Korea | 20050061588 | COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTININ THERAPY | ⤷ Try a Trial |
| Australia | 2004283431 | ⤷ Try a Trial | |
| European Patent Office | 1307232 | COMPOSITION POUR L'ADMINISTRATION TRANSDERMIQUE ET/OU TRANSMUQUEUSE DE COMPOSES ACTIFS ASSURANT DES NIVEAUX D'EFFICACITE THERAPEUTIQUE ADEQUATS (NOVEL COMPOSITION FOR TRANSDERMAL AND/OR TRANSMUCOSAL ADMINISTRATION OF ACTIVE COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC LEVELS) | ⤷ Try a Trial |
| Spain | 2283425 | ⤷ 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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