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Last Updated: March 22, 2023

BRYHALI Drug Patent Profile


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Which patents cover Bryhali, and what generic alternatives are available?

Bryhali is a drug marketed by Bausch and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in fifteen countries.

The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bryhali

A generic version of BRYHALI was approved as halobetasol propionate by FOUGERA PHARMS on December 16th, 2004.

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Drug patent expirations by year for BRYHALI
Drug Prices for BRYHALI

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Recent Clinical Trials for BRYHALI

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SponsorPhase
Bausch Health Americas, Inc.Phase 3
Icahn School of Medicine at Mount SinaiPhase 3

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Pharmacology for BRYHALI
Paragraph IV (Patent) Challenges for BRYHALI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRYHALI Lotion halobetasol propionate 0.01% 209355 1 2019-05-15

US Patents and Regulatory Information for BRYHALI

BRYHALI is protected by two US patents.

Patents protecting BRYHALI


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for BRYHALI

See the table below for patents covering BRYHALI around the world.

Country Patent Number Title Estimated Expiration
Austria 429922 See Plans and Pricing
South Korea 20180015281 국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) See Plans and Pricing
Israel 226398 פורמולציות רקחייות המכילות קורטיקוסטראוידים למתן על העור (Pharmaceutical formulations containing corticosteroids for topical administration) See Plans and Pricing
Portugal 2052714 See Plans and Pricing
Cyprus 1109189 See Plans and Pricing
Poland 213237 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRYHALI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom See Plans and Pricing PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 122013000081 Germany See Plans and Pricing PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 C300617 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992 2013C/060 Belgium See Plans and Pricing PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 CR 2013 00053 Denmark See Plans and Pricing PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992 92401 Luxembourg See Plans and Pricing PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Express Scripts
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.