Halobetasol propionate; tazarotene - Generic Drug Details

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What are the generic sources for halobetasol propionate; tazarotene and what is the scope of patent protection?

Halobetasol propionate; tazarotene is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate; tazarotene has fifty-four patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for halobetasol propionate; tazarotene

International Patents:	54
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for halobetasol propionate; tazarotene
DailyMed Link:	halobetasol propionate; tazarotene at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for halobetasol propionate; tazarotene

Generic Entry Date for halobetasol propionate; tazarotene^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: LOTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for halobetasol propionate; tazarotene

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

Sponsor	Phase
Dermatology Consulting Services, PLLC	Phase 4
Taro Pharmaceuticals USA	Early Phase 1
Bausch Health Americas, Inc.	Phase 4

See all halobetasol propionate; tazarotene clinical trials

Pharmacology for halobetasol propionate; tazarotene

Drug Class	Corticosteroid Retinoid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for halobetasol propionate; tazarotene

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE; TAZAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUOBRII	Lotion	halobetasol propionate; tazarotene	0.01%/0.045%	209354	1	2020-06-11

US Patents and Regulatory Information for halobetasol propionate; tazarotene

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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	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 halobetasol propionate; tazarotene

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for halobetasol propionate; tazarotene

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Country	Patent Number	Title	Estimated Expiration
South Korea	20140043044	PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION	⤷ Sign Up
China	108282998	用于治疗银屑病的包含皮质类固醇和类视黄醇的局部组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)	⤷ Sign Up
Russian Federation	2568598	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)	⤷ Sign Up
Canada	3063371	COMPOSITIONS TOPIQUES ET METHODES DE TRAITEMENT DE MALADIES CUTANES (TOPICAL COMPOSITIONS AND METHODS FOR TREATING SKIN DISEASES)	⤷ Sign Up
Japan	2018526325	乾癬を治療するためのコルチコステロイドおよびレチノイドを含む局所用組成物	⤷ Sign Up
Japan	7410720		⤷ Sign Up
Brazil	112017027332	composições tópicas que compreendem um corticosteróide e um retinóide para tratar psoríase.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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