Acanya is a drug owned by Bausch Health Americas Inc. It is protected by 7 US drug patents filed from 2013 to 2020. Out of these, 6 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 05, 2029. Details of Acanya'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5733886 | Compositions of clindamycin and benzoyl peroxide for acne treatment |
Mar, 2015
(9 years ago) |
Expired
|
| US10220049 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Jun, 2029
(4 years from now) | Active |
| US10624918 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Jun, 2029
(4 years from now) | Active |
| US8895070 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Jun, 2029
(4 years from now) | Active |
| US8663699 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Jun, 2029
(4 years from now) | Active |
| US9078870 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Jun, 2029
(4 years from now) | Active |
| US8288434 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Aug, 2029
(5 years from now) | Active |
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 Acanya's patents.
Latest Legal Activities on Acanya's Patents
Given below is the list of recent legal activities going on the following patents of Acanya.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Mar, 2024 | US8288434 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Sep, 2023 | US10624918 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Dec, 2022 | US9078870 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Aug, 2022 | US10220049 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2022 | US8895070 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2021 | US8663699 (Litigated) |
| Patent Issue Date Used in PTA Calculation | 21 Apr, 2020 | US10624918 |
| Recordation of Patent Grant Mailed | 21 Apr, 2020 | US10624918 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Apr, 2020 | US8288434 (Litigated) |
| Email Notification | 02 Apr, 2020 | US10624918 |
US patents provide insights into the exclusivity only within the United States, but Acanya 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 Acanya's family patents as well as insights into ongoing legal events on those patents.
Acanya's family patents
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Generic Launch
Generic Release Date:
Acanya's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 05, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acanya Generics:
Benzoyl Peroxide; Clindamycin Phosphate is the generic name for the brand Acanya. 8 different companies have already filed for the generic of Acanya, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Acanya's generic
How can I launch a generic of Acanya before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Acanya's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Acanya'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 Acanya -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.2%/2.5% | 20 Dec, 2012 | 1 | 19 Jun, 2015 | 05 Aug, 2029 | Eligible |
| 1.2%/3.75% | 30 Sep, 2015 | 1 | 05 Jun, 2018 | 05 Aug, 2029 | Eligible |
About Acanya
Acanya is a drug owned by Bausch Health Americas Inc. It is used for treating acne vulgaris in patients 12 years or older. Acanya uses Benzoyl Peroxide; Clindamycin Phosphate as an active ingredient. Acanya was launched by Bausch in 2008.
Market Authorisation Date:
Acanya was approved by FDA for market use on 23 October, 2008.
Active Ingredient:
Acanya uses Benzoyl Peroxide; Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide; Clindamycin Phosphate ingredient
Treatment:
Acanya is used for treating acne vulgaris in patients 12 years or older.
Dosage:
Acanya is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5%;EQ 1.2% BASE | GEL | Prescription | TOPICAL |