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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7198801 | Formulations for transdermal or transmucosal application |
Jun, 2022
(3 years ago) |
Expired
|
| US7029694 | Compositions and methods for transdermal oxybutynin therapy |
Apr, 2020
(5 years ago) |
Expired
|
| US7179483 | Compositions and methods for transdermal oxybutynin therapy |
Apr, 2020
(5 years ago) |
Expired
|
| US8241662 | Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy |
Apr, 2020
(5 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%.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed
Critical | 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
Critical | 14 Aug, 2012 | US8241662 |
| Patent Issue Date Used in PTA Calculation
Critical | 14 Aug, 2012 | US8241662 |
| Issue Notification Mailed
Critical | 25 Jul, 2012 | US8241662 |
| Dispatch to FDC | 17 Jul, 2012 | US8241662 |
| Application Is Considered Ready for Issue
Critical | 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
Explore Our Curated Drug Screens
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% Generic API suppliers:
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
Alternative Brands for Gelnique 3%
Gelnique 3% which is used for managing symptoms of an overactive bladder., has several other brand drugs in the same treatment category and using the same active ingredient (Oxybutynin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Oxybutynin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
| |
| Janssen Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxybutynin, Gelnique 3%'s active ingredient. Check the complete list of approved generic manufacturers for Gelnique 3%
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.
Approval 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 |