Duobrii is a drug owned by Bausch Health Americas Inc. It is protected by 10 US drug patents filed from 2019 to 2024. 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 Jun 06, 2036. Details of Duobrii'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). | |||
| US6517847 | Topical gel delivery system |
Aug, 2020
(3 years ago) |
Expired
|
| US11957753 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(7 years from now) | Active |
| US11839656 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(7 years from now) | Active |
| US11986527 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(7 years from now) | Active |
| US8809307 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(7 years from now) | Active |
| US10478502 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(7 years from now) | Active |
| US11648256 | Topical compositions and methods for treating psoriasis |
Jun, 2036
(11 years from now) | Active |
| US11679115 | Topical compositions and methods for treating psoriasis |
Jun, 2036
(11 years from now) | Active |
| US10426787 | Topical compositions and methods for treating psoriasis |
Jun, 2036
(11 years from now) | Active |
| US10251895 | Topical compositions and methods for treating psoriasis |
Jun, 2036
(11 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 Duobrii's patents.
Latest Legal Activities on Duobrii's Patents
Given below is the list of recent legal activities going on the following patents of Duobrii.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 12 Dec, 2023 | US11839656 |
| Email Notification | 12 Dec, 2023 | US11839656 |
| Mail Patent eGrant Notification | 12 Dec, 2023 | US11839656 |
| Recordation of Patent Grant Mailed | 12 Dec, 2023 | US11839656 |
| Patent eGrant Notification | 12 Dec, 2023 | US11839656 |
| Recordation of Patent eGrant | 12 Dec, 2023 | US11839656 |
| Email Notification | 23 Nov, 2023 | US11839656 |
| Issue Notification Mailed | 22 Nov, 2023 | US11839656 |
| Dispatch to FDC | 08 Nov, 2023 | US11839656 |
| Application Is Considered Ready for Issue | 08 Nov, 2023 | US11839656 |
FDA has granted several exclusivities to Duobrii. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Duobrii, 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 Duobrii.
Exclusivity Information
Duobrii holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Duobrii's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 25, 2022 |
US patents provide insights into the exclusivity only within the United States, but Duobrii 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 Duobrii's family patents as well as insights into ongoing legal events on those patents.
Duobrii's family patents
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Generic Launch
Generic Release Date:
Duobrii's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 06, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duobrii Generics:
There are no approved generic versions for Duobrii as of now.
How can I launch a generic of Duobrii before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Duobrii's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Duobrii'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 Duobrii -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.01%/0.045% | 11 Jun, 2020 | 1 | 06 Jun, 2036 |
About Duobrii
Duobrii is a drug owned by Bausch Health Americas Inc. It is used for treating plaque psoriasis in adults. Duobrii uses Halobetasol Propionate; Tazarotene as an active ingredient. Duobrii was launched by Bausch in 2019.
Market Authorisation Date:
Duobrii was approved by FDA for market use on 25 April, 2019.
Active Ingredient:
Duobrii uses Halobetasol Propionate; Tazarotene as the active ingredient. Check out other Drugs and Companies using Halobetasol Propionate; Tazarotene ingredient
Treatment:
Duobrii is used for treating plaque psoriasis in adults.
Dosage:
Duobrii is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.01%;0.045% | LOTION | Prescription | TOPICAL |