Gelnique 3% is a drug owned by Allergan Sales Llc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 25, 2022. Details of Gelnique 3%'s patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7029694 | Compositions and methods for transdermal oxybutynin therapy |
Apr, 2020
(4 years ago) |
Expired
|
| US7179483 | Compositions and methods for transdermal oxybutynin therapy |
Apr, 2020
(4 years ago) |
Expired
|
| US8241662 | Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy |
Apr, 2020
(4 years ago) |
Expired
|
| US7198801 | Formulations for transdermal or transmucosal application |
Jun, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gelnique 3%'s patents.
Latest Legal Activities on Gelnique 3%'s Patents
Given below is the list of recent legal activities going on the following patents of Gelnique 3%.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 01 Apr, 2024 | US8241662 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Feb, 2020 | US8241662 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2018 | US7198801 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Aug, 2018 | US7179483 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2017 | US7029694 (Litigated) |
| Recordation of Patent Grant Mailed | 14 Aug, 2012 | US8241662 |
| Patent Issue Date Used in PTA Calculation | 14 Aug, 2012 | US8241662 |
| Issue Notification Mailed | 25 Jul, 2012 | US8241662 |
| Dispatch to FDC | 17 Jul, 2012 | US8241662 |
| Application Is Considered Ready for Issue | 02 Jul, 2012 | US8241662 |
FDA has granted several exclusivities to Gelnique 3%. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gelnique 3%, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gelnique 3%.
Exclusivity Information
Gelnique 3% holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Gelnique 3%'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 07, 2014 |
US patents provide insights into the exclusivity only within the United States, but Gelnique 3% is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gelnique 3%'s family patents as well as insights into ongoing legal events on those patents.
Gelnique 3%'s family patents
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Generic Launch
Generic Release Date:
Gelnique 3%'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 25, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gelnique 3% Generics:
Oxybutynin is the generic name for the brand Gelnique 3%. 1 company has already filed for the generic of Gelnique 3%. Check out the entire list of companies who have already received approval for Gelnique 3%'s generic
About Gelnique 3%
Gelnique 3% is a drug owned by Allergan Sales Llc. It is used for managing symptoms of an overactive bladder. Gelnique 3% uses Oxybutynin as an active ingredient. Gelnique 3% was launched by Allergan in 2011.
Market Authorisation Date:
Gelnique 3% was approved by FDA for market use on 07 December, 2011.
Active Ingredient:
Gelnique 3% uses Oxybutynin as the active ingredient. Check out other Drugs and Companies using Oxybutynin ingredient
Treatment:
Gelnique 3% is used for managing symptoms of an overactive bladder.
Dosage:
Gelnique 3% is available in gel, metered form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3% | GEL, METERED | Discontinued | TRANSDERMAL |