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Last Updated: May 29, 2020

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BRYHALI Drug 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 three patents protecting this drug.

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

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

US ANDA 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 Litigation for BRYHALI

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District Court Litigation
Case NameDate
BAUSCH HEALTH IRELAND LIMITED v. GLENMARK PHARMACEUTICALS LIMITED2019-06-28

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Pharmacology for BRYHALI
Paragraph IV (Patent) Challenges for BRYHALI
Tradename Dosage Ingredient NDA Submissiondate
BRYHALI LOTION;TOPICAL halobetasol propionate 209355 2019-05-15

US Patents and Regulatory Information for BRYHALI

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

Supplementary Protection Certificates for BRYHALI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 C300617 Netherlands   Start Trial 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 132013902214376 Italy   Start Trial PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 CR 2013 00053 Denmark   Start Trial PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania   Start Trial PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Harvard Business School
Medtronic
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.