Gelnique is a drug owned by Abbvie Inc. It is protected by 7 US drug patents filed from 2013 to 2019. Out of these, 3 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 26, 2031. Details of Gelnique'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). | |||
| US8920392 | Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions |
Mar, 2031
(6 years from now) | Active |
| US10449173 | Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions |
Nov, 2029
(4 years from now) | Active |
| US9259388 | Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions |
Nov, 2029
(4 years from now) | Active |
| US7179483 | Compositions and methods for transdermal oxybutynin therapy |
Apr, 2020
(4 years ago) |
Expired
|
| US7029694 | 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
|
| US10272061 | Compositions and methods for unoccluded transdermal oxybutynin therapy |
Apr, 2020
(4 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's patents.
Latest Legal Activities on Gelnique's Patents
Given below is the list of recent legal activities going on the following patents of Gelnique.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Apr, 2024 | US8241662 |
| Expire Patent Critical | 05 Jun, 2023 | US10272061 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Mar, 2023 | US10449173 |
| Maintenance Fee Reminder Mailed Critical | 19 Dec, 2022 | US10272061 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 May, 2022 | US8920392 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Feb, 2020 | US8241662 |
| Recordation of Patent Grant Mailed Critical | 22 Oct, 2019 | US10449173 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Oct, 2019 | US10449173 |
| Issue Notification Mailed Critical | 02 Oct, 2019 | US10449173 |
| Dispatch to FDC | 16 Sep, 2019 | US10449173 |
FDA has granted several exclusivities to Gelnique. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gelnique, 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.
Exclusivity Information
Gelnique holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Gelnique's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jan 27, 2012 |
US patents provide insights into the exclusivity only within the United States, but Gelnique 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's family patents as well as insights into ongoing legal events on those patents.
Gelnique's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gelnique's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 26, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gelnique Generic API suppliers:
Oxybutynin Chloride is the generic name for the brand Gelnique. 29 different companies have already filed for the generic of Gelnique, with Bionpharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gelnique's generic
How can I launch a generic of Gelnique before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gelnique's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gelnique's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Gelnique -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 | 19 Jun, 2014 | 1 | 31 May, 2018 | 26 Apr, 2020 | Extinguished Deferred |
Alternative Brands for Gelnique
Gelnique which is used for treating overactive bladder symptoms with oxybutynin chloride gel., has several other brand drugs in the same treatment category and using the same active ingredient (Oxybutynin Chloride). 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.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Allergan |
| |||||
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 Chloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Janssen Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxybutynin Chloride, Gelnique's active ingredient. Check the complete list of approved generic manufacturers for Gelnique
About Gelnique
Gelnique is a drug owned by Abbvie Inc. It is used for treating overactive bladder symptoms with oxybutynin chloride gel. Gelnique uses Oxybutynin Chloride as an active ingredient. Gelnique was launched by Abbvie in 2009.
Approval Date:
Gelnique was approved by FDA for market use on 27 January, 2009.
Active Ingredient:
Gelnique uses Oxybutynin Chloride as the active ingredient. Check out other Drugs and Companies using Oxybutynin Chloride ingredient
Treatment:
Gelnique is used for treating overactive bladder symptoms with oxybutynin chloride gel.
Dosage:
Gelnique is available in gel form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | TRANSDERMAL |