BRYHALI Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in nineteen 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 16^th, 2004.

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Summary for BRYHALI

International Patents:	26
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	4,752
Drug Prices:	Drug price information for BRYHALI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRYHALI
What excipients (inactive ingredients) are in BRYHALI?	BRYHALI excipients list
DailyMed Link:	BRYHALI at DailyMed

Drug patent expirations by year for BRYHALI

Recent Clinical Trials for BRYHALI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	Phase 3
Bausch Health Americas, Inc.	Phase 3

See all BRYHALI clinical trials

Pharmacology for BRYHALI

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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 six US patents.

Patents protecting BRYHALI

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Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

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Patent Expiration: ⤷ Sign Up

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Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

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Pharmaceutical formulations containing corticosteroids for topical administration
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Glossary

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

Expired US Patents for BRYHALI

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BRYHALI

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0211683		⤷ Sign Up
South Korea	20140043044	PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION	⤷ Sign Up
Mexico	346961	FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012087443		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BRYHALI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	122013000081	Germany	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	2013C/060	Belgium	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	132013902214376	Italy	⤷ Sign Up	PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description