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 three 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:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	5,226
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
Bausch Health Americas, Inc.	Phase 3
Icahn School of Medicine at Mount Sinai	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 three US patents.

Patents protecting BRYHALI

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
>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
Russian Federation	2013128607	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ	⤷ Try a Trial
China	101305982		⤷ Try a Trial
South Korea	20180015281	국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)	⤷ Try a Trial
Brazil	112013012476	formulações farmacêuticas contendo corticosteróides para administração tópica	⤷ Try a Trial
Slovenia	2643002		⤷ Try a Trial
Mexico	346961	FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)	⤷ Try a Trial
>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	132013902214376	Italy	⤷ Try a Trial	PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	1390049-3	Sweden	⤷ Try a Trial	PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	122013000081	Germany	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	PA2013025	Lithuania	⤷ Try a Trial	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	CR 2013 00053	Denmark	⤷ Try a 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	92401	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for BRYHALI

Recent Clinical Trials for BRYHALI

Pharmacology for BRYHALI

Paragraph IV (Patent) Challenges for BRYHALI

Patents protecting BRYHALI

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