Qutenza is a drug owned by Averitas Pharma Inc. It is protected by 8 US drug patents filed from 2013 to 2021. Out of these, 3 drug patents are active and 5 have expired. Qutenza's patents have been open to challenges since 16 November, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 26, 2030. Details of Qutenza'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). | |||
| US8821920 | Therapeutic patch for transdermal delivery of capsaicin |
Mar, 2030
(5 years from now) | Active |
| US9226903 | Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer |
Dec, 2028
(4 years from now) | Active |
| US10034841 | Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer |
Sep, 2025
(10 months from now) | Active |
| US8263059 | Compositions and kits for the removal of irritating compounds from bodily surfaces |
Sep, 2023
(1 year, 1 month ago) |
Expired
|
| US10463598 | Compositions and kits for the removal of irritating compounds from bodily surfaces |
Sep, 2023
(1 year, 1 month ago) |
Expired
|
| US10869827 | Compositions and kits for the removal of irritating compounds from bodily surfaces |
Sep, 2023
(1 year, 1 month ago) |
Expired
|
| US8889113 | Compositions and kits for the removal of irritating compounds from bodily surfaces |
Sep, 2023
(1 year, 1 month ago) |
Expired
|
| US6239180 | Transdermal therapeutic device and method with capsaicin and capsaicin analogs |
Nov, 2016
(7 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 Qutenza's patents.
Latest Legal Activities on Qutenza's Patents
Given below is the list of recent legal activities going on the following patents of Qutenza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 29 Apr, 2024 | US8263059 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Jun, 2023 | US9226903 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Apr, 2023 | US10463598 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2022 | US8889113 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Feb, 2022 | US8821920 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2022 | US10034841 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Dec, 2020 | US10869827 |
| Recordation of Patent Grant Mailed Critical | 22 Dec, 2020 | US10869827 |
| Email Notification Critical | 03 Dec, 2020 | US10869827 |
| Issue Notification Mailed Critical | 02 Dec, 2020 | US10869827 |
FDA has granted several exclusivities to Qutenza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qutenza, 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 Qutenza.
Exclusivity Information
Qutenza holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Qutenza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 16, 2014 |
| Orphan Drug Exclusivity(ODE) | Nov 16, 2016 |
| New Indication(I-838) | Jul 17, 2023 |
US patents provide insights into the exclusivity only within the United States, but Qutenza 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 Qutenza's family patents as well as insights into ongoing legal events on those patents.
Qutenza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qutenza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 26, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qutenza Generics:
There are no approved generic versions for Qutenza as of now.
About Qutenza
Qutenza is a drug owned by Averitas Pharma Inc. It is used for removing capsaicin from a treatment area or unintended area. Qutenza uses Capsaicin as an active ingredient. Qutenza was launched by Averitas in 2009.
Approval Date:
Qutenza was approved by FDA for market use on 16 November, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Qutenza is 16 November, 2009, its NCE-1 date is estimated to be 16 November, 2013.
Active Ingredient:
Qutenza uses Capsaicin as the active ingredient. Check out other Drugs and Companies using Capsaicin ingredient
Treatment:
Qutenza is used for removing capsaicin from a treatment area or unintended area.
Dosage:
Qutenza is available in patch form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 8% | PATCH | Prescription | TOPICAL |