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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 209354

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NDA 209354 describes DUOBRII, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the DUOBRII profile page.

The generic ingredient in DUOBRII is halobetasol propionate; tazarotene. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the halobetasol propionate; tazarotene profile page.

Summary for 209354

Tradename:	DUOBRII
Applicant:	Bausch
Ingredient:	halobetasol propionate; tazarotene
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209354

Generic Entry Date for 209354^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Pharmacology for NDA: 209354

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 209354

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653	0187-0653-01	1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE
DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653	0187-0653-03	6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.01%;0.045%
Approval Date:	Apr 25, 2019	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 6, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 6, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 2, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

Expired US Patents for NDA 209354

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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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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