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Last Updated: January 18, 2020

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BRYHALI Drug Profile

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When do Bryhali patents expire, and when can generic versions of Bryhali launch?

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. Ten 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

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A generic version of BRYHALI was approved as halobetasol propionate by FOUGERA PHARMS on January 18th, 2020.

Drug patent expirations by year for BRYHALI
Drug Prices for BRYHALI

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Recent Litigation for BRYHALI

Identify potential future generic entrants

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

See all BRYHALI litigation

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 1390049-3 Sweden   Start Trial PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 474 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Baxter
Johnson and Johnson
AstraZeneca
Merck

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