Aczone is a drug owned by Almirall Llc. It is protected by 6 US drug patents filed from 2016 to 2022. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 18, 2033. Details of Aczone'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). | |||
| US9161926 | Topical dapsone and dapsone/adaplene compositions and methods for use thereof |
Nov, 2033
(8 years from now) | Active |
| US9517219 | Topical dapsone and dapsone/adapalene compositions and methods for use thereof |
Nov, 2033
(8 years from now) | Active |
| US11273132 | Topical dapsone and dapsone/adapalene compositions and methods for use thereof |
Nov, 2033
(8 years from now) | Active |
| US5863560 | Compositions and methods for topical application of therapeutic agents |
Sep, 2016
(8 years ago) |
Expired
|
| US6620435 | Compositions for topical application of therapeutic agents |
Sep, 2016
(8 years ago) |
Expired
|
| US6060085 | Compositions and methods for topical application of therapeutic agents |
Sep, 2016
(8 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 Aczone's patents.
Latest Legal Activities on Aczone's Patents
Given below is the list of recent legal activities going on the following patents of Aczone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9161926 |
| Review Certificate Mailed | 26 Sep, 2022 | US9517219 |
| Review Certificate | 16 Sep, 2022 | US9517219 |
| AIA Appeal returned from Federal Circuit | 16 Sep, 2022 | US9517219 |
| Recordation of Patent Grant Mailed Critical | 15 Mar, 2022 | US11273132 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Mar, 2022 | US11273132 |
| Email Notification Critical | 24 Feb, 2022 | US11273132 |
| Issue Notification Mailed Critical | 23 Feb, 2022 | US11273132 |
| Dispatch to FDC | 10 Feb, 2022 | US11273132 |
| Application Is Considered Ready for Issue Critical | 10 Feb, 2022 | US11273132 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Aczone and ongoing litigations to help you estimate the early arrival of Aczone generic.
Aczone's Litigations
Aczone been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 12, 2018, against patent number US9161926. The petitioner Amneal Pharmceuticals LLC, challenged the validity of this patent, with Almirall, LLC as the respondent. Click below to track the latest information on how companies are challenging Aczone's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9517219 | November, 2018 |
FWD Entered
(29 May, 2020) | Almirall, LLC | Amneal Pharmaceuticals LLC |
| US9517219 | June, 2019 |
FWD Entered
(29 May, 2020) | Almirall, LLC | Mylan Pharmaceuticals Inc. |
| US9161926 | February, 2018 |
FWD Entered
(27 Aug, 2019) | Almirall, LLC | Amneal Pharmceuticals LLC |
FDA has granted some exclusivities to Aczone. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aczone, 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 Aczone.
Exclusivity Information
Aczone holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Aczone's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Feb 24, 2019 |
| New Patient Population(NPP) | Sep 10, 2022 |
US patents provide insights into the exclusivity only within the United States, but Aczone 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 Aczone's family patents as well as insights into ongoing legal events on those patents.
Aczone's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aczone's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 18, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aczone Generic API suppliers:
Dapsone is the generic name for the brand Aczone. 17 different companies have already filed for the generic of Aczone, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aczone's generic
How can I launch a generic of Aczone before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aczone's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aczone'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 Aczone -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.075 | 13 Feb, 2017 | 1 | 26 Jun, 2019 | 18 Nov, 2033 | Eligible |
Alternative Brands for Aczone
Aczone which is used for treating acne vulgaris through topical application., has several other brand drugs in the same treatment category . 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Bausch |
| |||||||||
| Galderma Labs Lp |
| |||||||||
| Journey |
| |||||||||
About Aczone
Aczone is a drug owned by Almirall Llc. It is used for treating acne vulgaris through topical application. Aczone uses Dapsone as an active ingredient. Aczone was launched by Almirall in 2016.
Approval Date:
Aczone was approved by FDA for market use on 24 February, 2016.
Active Ingredient:
Aczone uses Dapsone as the active ingredient. Check out other Drugs and Companies using Dapsone ingredient
Treatment:
Aczone is used for treating acne vulgaris through topical application.
Dosage:
Aczone is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 7.5% | GEL | Prescription | TOPICAL |
Aczone is a drug owned by Abbvie Inc. It is protected by 3 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 Sep 10, 2022. Details of Aczone'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). | |||
| US6620435 | Compositions for topical application of therapeutic agents |
Sep, 2016
(8 years ago) |
Expired
|
| US5863560 | Compositions and methods for topical application of therapeutic agents |
Sep, 2016
(8 years ago) |
Expired
|
| US6060085 | Compositions and methods for topical application of therapeutic agents |
Sep, 2016
(8 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 Aczone's patents.
Latest Legal Activities on Aczone's Patents
Given below is the list of recent legal activities going on the following patents of Aczone.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9161926 |
| Review Certificate Mailed | 26 Sep, 2022 | US9517219 |
| Review Certificate | 16 Sep, 2022 | US9517219 |
| AIA Appeal returned from Federal Circuit | 16 Sep, 2022 | US9517219 |
| Recordation of Patent Grant Mailed Critical | 15 Mar, 2022 | US11273132 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Mar, 2022 | US11273132 |
| Email Notification Critical | 24 Feb, 2022 | US11273132 |
| Issue Notification Mailed Critical | 23 Feb, 2022 | US11273132 |
| Dispatch to FDC | 10 Feb, 2022 | US11273132 |
| Application Is Considered Ready for Issue Critical | 10 Feb, 2022 | US11273132 |
FDA has granted several exclusivities to Aczone. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aczone, 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 Aczone.
Exclusivity Information
Aczone holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Aczone's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Feb 24, 2019 |
| New Patient Population(NPP) | Sep 10, 2022 |
US patents provide insights into the exclusivity only within the United States, but Aczone 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 Aczone's family patents as well as insights into ongoing legal events on those patents.
Aczone's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aczone's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 10, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aczone Generic API suppliers:
Dapsone is the generic name for the brand Aczone. 17 different companies have already filed for the generic of Aczone, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aczone's generic
How can I launch a generic of Aczone before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aczone's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aczone'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 Aczone -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.075 | 13 Feb, 2017 | 1 | 26 Jun, 2019 | 18 Nov, 2033 | Eligible |
Alternative Brands for Aczone
Aczone which is used for treating acne vulgaris through topical application., has several other brand drugs in the same treatment category . 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Bausch |
| |||||||||
| Galderma Labs Lp |
| |||||||||
| Journey |
| |||||||||
About Aczone
Aczone is a drug owned by Abbvie Inc. It is used for treating acne vulgaris through topical application. Aczone uses Dapsone as an active ingredient. Aczone was launched by Abbvie in 2005.
Approval Date:
Aczone was approved by FDA for market use on 07 July, 2005.
Active Ingredient:
Aczone uses Dapsone as the active ingredient. Check out other Drugs and Companies using Dapsone ingredient
Treatment:
Aczone is used for treating acne vulgaris through topical application.
Dosage:
Aczone is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | GEL | Prescription | TOPICAL |