Qbrexza is a drug owned by Journey Medical Corp. It is protected by 10 US drug patents filed from 2018 to 2020. Out of these, 9 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2033. Details of Qbrexza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10548875 | Glycopyrrolate salts |
Feb, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9006462 | Glycopyrrolate salts |
Feb, 2033
(8 years from now) | Active |
| US9259414 | Glycopyrrolate salts |
Feb, 2033
(8 years from now) | Active |
| US10004717 | Glycopyrrolate salts |
Feb, 2033
(8 years from now) | Active |
| US10543192 | Glycopyrrolate salts |
Feb, 2033
(8 years from now) | Active |
| US8859610 | Crystalline glycopyrrolate tosylate |
Feb, 2033
(8 years from now) | Active |
| US9744105 | Topical glycopyrrolate formulations |
Jul, 2030
(5 years from now) | Active |
| US8618160 | Topical glycopyrrolate formulations |
Dec, 2029
(5 years from now) | Active |
| US10052267 | Topical glycopyrrolate formulations |
Oct, 2028
(3 years from now) | Active |
| US6433003 | Method for treating hyperhidrosis in mammals |
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 Qbrexza's patents.
Latest Legal Activities on Qbrexza's Patents
Given below is the list of recent legal activities going on the following patents of Qbrexza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Requirement for information sent under 37 CFR 1.750 | 22 Jan, 2024 | US8618160 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Aug, 2023 | US10548875 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jul, 2023 | US10543192 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Apr, 2022 | US8859610 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Feb, 2022 | US10052267 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Dec, 2021 | US10004717 |
| 7.5 yr surcharge - late pmt w/in 6 mo, Large Entity | 07 Sep, 2021 | US8618160 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Sep, 2021 | US8618160 |
| Maintenance Fee Reminder Mailed Critical | 23 Aug, 2021 | US8618160 |
| Second letter to regulating agency to determine regulatory review period | 03 May, 2021 | US8618160 |
FDA has granted several exclusivities to Qbrexza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qbrexza, 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 Qbrexza.
Exclusivity Information
Qbrexza holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Qbrexza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 28, 2021 |
US patents provide insights into the exclusivity only within the United States, but Qbrexza 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 Qbrexza's family patents as well as insights into ongoing legal events on those patents.
Qbrexza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qbrexza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qbrexza Generics:
There are no approved generic versions for Qbrexza as of now.
How can I launch a generic of Qbrexza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Qbrexza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qbrexza'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 Qbrexza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.024 | 13 Jan, 2020 | 1 | 28 Feb, 2033 |
About Qbrexza
Qbrexza is a drug owned by Journey Medical Corp. It is used for reducing excessive sweating in the underarms in adults and children 9 years of age and older. Qbrexza uses Glycopyrronium Tosylate as an active ingredient. Qbrexza was launched by Journey in 2018.
Approval Date:
Qbrexza was approved by FDA for market use on 28 June, 2018.
Active Ingredient:
Qbrexza uses Glycopyrronium Tosylate as the active ingredient. Check out other Drugs and Companies using Glycopyrronium Tosylate ingredient
Treatment:
Qbrexza is used for reducing excessive sweating in the underarms in adults and children 9 years of age and older.
Dosage:
Qbrexza is available in cloth form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.4% BASE | CLOTH | Prescription | TOPICAL |