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Last Updated: January 27, 2022

DrugPatentWatch Database Preview

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 eighteen patent family members in twelve countries.

The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Twelve 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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Summary for BRYHALI
Drug patent expirations by year for BRYHALI
Drug Prices for BRYHALI

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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

BRYHALI is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting BRYHALI


Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

FDA Regulatory Exclusivity protecting BRYHALI

NEW PRODUCT
Exclusivity Expiration: ⤷  Try it Free

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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 SPC/GB13/061 United Kingdom ⤷  Try it Free PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 PA2013025,C1304992 Lithuania ⤷  Try it Free 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
1304992 PA2013025 Lithuania ⤷  Try it Free PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992 92401 Luxembourg ⤷  Try it Free PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 132013902214376 Italy ⤷  Try it Free PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 2013C/060 Belgium ⤷  Try it Free PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
>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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Moodys

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