Bryhali Patent Expiration

Bryhali is a drug owned by Bausch Health Americas Inc. It is protected by 4 US drug patents filed from 2019 to 2023. Out of these, 3 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6517847 Topical gel delivery system
Aug, 2020

(3 years ago)

Expired
US10478502 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
US8809307 Pharmaceutical formulations containing corticosteroids for topical administration
Nov, 2031

(7 years from now)

Active


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




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.

Market Authorisation 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