Bryhali Patent Expiration

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

(7 years from now)

Active
US10478502 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
US11957753 Pharmaceutical formulations containing corticosteroids for topical administration
Nov, 2031

(7 years from now)

Active
US12076403 Pharmaceutical formulations containing corticosteroids for topical administration
Nov, 2031

(7 years from now)

Active
US6517847 Topical gel delivery system
Aug, 2020

(4 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.

Given below is the list of recent legal activities going on the following patents of Bryhali.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 12 Dec, 2023 US11839656
Recordation of Patent eGrant 12 Dec, 2023 US11839656
Email Notification 12 Dec, 2023 US11839656
Recordation of Patent Grant Mailed 12 Dec, 2023 US11839656
Patent eGrant Notification 12 Dec, 2023 US11839656
Mail Patent eGrant Notification 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 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

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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

Bryhali has patent protection in a total of 18 countries. It's US patent count contributes only to 32.1% of its total global patent coverage. Click below to unlock the full patent family tree for Bryhali.

Family Patents

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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 Generics:

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.

Drug Owner Drug Name Treatment Area
Bausch
Duobrii

(uses Halobetasol Propionate)

Used for treating plaque psoriasis in adults.
Dermavant Sci
Vtama Used for managing plaque psoriasis in adults through topical application.

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.

Drug Owner Drug Name
Mayne Pharma
Lexette
Mical Pharms
Ultravate


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