Onexton is a drug owned by Bausch Health Americas Inc. It is protected by 6 US drug patents filed from 2014 to 2019. Out of these, 5 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 Onexton'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). | |||
| US8288434 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
Aug, 2029
(4 years from now) | Active |
| 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 |
| US9504704 | 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 |
| US10137142 | 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 |
| US9561208 | 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 |
| US5733886 | Compositions of clindamycin and benzoyl peroxide for acne treatment |
Mar, 2015
(9 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 Onexton's patents.
Latest Legal Activities on Onexton's Patents
Given below is the list of recent legal activities going on the following patents of Onexton.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Apr, 2024 | US9504704 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Mar, 2024 | US8288434 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Aug, 2022 | US10220049 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Apr, 2022 | US10137142 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Jul, 2020 | US9561208 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Apr, 2020 | US9504704 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Apr, 2020 | US8288434 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 05 Mar, 2019 | US10220049 |
| Recordation of Patent Grant Mailed Critical | 05 Mar, 2019 | US10220049 |
| Email Notification Critical | 14 Feb, 2019 | US10220049 |
US patents provide insights into the exclusivity only within the United States, but Onexton 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 Onexton's family patents as well as insights into ongoing legal events on those patents.
Onexton's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Onexton'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)
Onexton Generic API suppliers:
Benzoyl Peroxide; Clindamycin Phosphate is the generic name for the brand Onexton. 8 different companies have already filed for the generic of Onexton, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onexton's generic
How can I launch a generic of Onexton before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Onexton's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Onexton'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 Onexton -
| 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 |
Alternative Brands for Onexton
Onexton which is used for treating acne vulgaris in patients 12 years or older., has several other brand drugs in the same treatment category and using the same active ingredient (Benzoyl Peroxide; Clindamycin Phosphate). 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 | ||||||
|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||
| Almirall |
| |||||||
| Bausch |
| |||||||
| Journey |
| |||||||
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. Benzoyl Peroxide; Clindamycin Phosphate. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Benzoyl Peroxide; Clindamycin Phosphate, Onexton's active ingredient. Check the complete list of approved generic manufacturers for Onexton
About Onexton
Onexton is a drug owned by Bausch Health Americas Inc. It is used for treating acne vulgaris in patients 12 years or older. Onexton uses Benzoyl Peroxide; Clindamycin Phosphate as an active ingredient. Onexton was launched by Bausch in 2008.
Approval Date:
Onexton was approved by FDA for market use on 23 October, 2008.
Active Ingredient:
Onexton uses Benzoyl Peroxide; Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide; Clindamycin Phosphate ingredient
Treatment:
Onexton is used for treating acne vulgaris in patients 12 years or older.
Dosage:
Onexton is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.75%;EQ 1.2% BASE | GEL | Prescription | TOPICAL |