Bryhali is a drug owned by Bausch Health Americas Inc. It is protected by 7 US drug patents filed from 2019 to 2024. 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 Nov 02, 2031. Details of Bryhali'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). | |||
| US11839656 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US10478502 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US11986527 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US8809307 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US11957753 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US12076403 | Pharmaceutical formulations containing corticosteroids for topical administration |
Nov, 2031
(6 years from now) | Active |
| US6517847 | Topical gel delivery system |
Aug, 2020
(5 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 Bryhali's patents.
Latest Legal Activities on Bryhali's Patents
Given below is the list of recent legal activities going on the following patents of Bryhali.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation
Critical | 12 Dec, 2023 | US11839656 |
| Recordation of Patent eGrant | 12 Dec, 2023 | US11839656 |
| Email Notification
Critical | 12 Dec, 2023 | US11839656 |
| Recordation of Patent Grant Mailed
Critical | 12 Dec, 2023 | US11839656 |
| Patent eGrant Notification | 12 Dec, 2023 | US11839656 |
| Mail Patent eGrant Notification | 12 Dec, 2023 | US11839656 |
| Email Notification
Critical | 23 Nov, 2023 | US11839656 |
| Issue Notification Mailed
Critical | 22 Nov, 2023 | US11839656 |
| Dispatch to FDC | 08 Nov, 2023 | US11839656 |
| Application Is Considered Ready for Issue
Critical | 08 Nov, 2023 | US11839656 |
FDA has granted several exclusivities to Bryhali. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Bryhali, 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
Bryhali.
Exclusivity Information
Bryhali holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Bryhali's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 06, 2021 |
US patents provide insights into the exclusivity only within the United States, but
Bryhali 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 Bryhali's family patents as well as insights into
ongoing legal events
on those patents.
Bryhali's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bryhali's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 02, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bryhali Generic API suppliers:
Halobetasol Propionate is the generic name for the brand Bryhali. 6 different companies have already filed for the generic of Bryhali, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bryhali's generic
How can I launch a generic of Bryhali before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bryhali's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bryhali'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 Bryhali -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0001 | 15 May, 2019 | 1 | 02 Nov, 2031 |
Alternative Brands for Bryhali
Bryhali which is used for treating plaque psoriasis in adults., has several other brand drugs in the same treatment category and using the same active ingredient (Halobetasol Propionate). 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.
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. Halobetasol Propionate. 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 Halobetasol Propionate, Bryhali's active ingredient. Check the complete list of approved generic manufacturers for Bryhali
About Bryhali
Bryhali is a drug owned by Bausch Health Americas Inc. It is used for treating plaque psoriasis in adults. Bryhali uses Halobetasol Propionate as an active ingredient. Bryhali was launched by Bausch in 2018.
Approval Date:
Bryhali was approved by FDA for market use on 06 November, 2018.
Active Ingredient:
Bryhali uses Halobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Halobetasol Propionate ingredient
Treatment:
Bryhali is used for treating plaque psoriasis in adults.
Dosage:
Bryhali is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.01% | LOTION | Prescription | TOPICAL |