DUOBRII Drug Patent Profile

When do Duobrii patents expire, and what generic alternatives are available?

Duobrii is a drug marketed by Bausch and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-one countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Duobrii

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DUOBRII

International Patents:	42
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DUOBRII
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUOBRII
What excipients (inactive ingredients) are in DUOBRII?	DUOBRII excipients list
DailyMed Link:	DUOBRII at DailyMed

See drug prices for DUOBRII

Recent Clinical Trials for DUOBRII

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

Sponsor	Phase
Austin Institute for Clinical Research	Phase 3
OrthoDermatologics	Phase 3
Taro Pharmaceuticals USA	Early Phase 1

See all DUOBRII clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DUOBRII

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

Paragraph IV (Patent) Challenges for DUOBRII

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 DUOBRII

DUOBRII is protected by four US patents and one FDA Regulatory Exclusivity.

Patents protecting DUOBRII

FDA Regulatory Exclusivity protecting DUOBRII

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

Expired US Patents for DUOBRII

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

International Patents for DUOBRII

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

Country	Patent Number	Title	Estimated Expiration
Portugal	3310389
South Korea	101967121
Serbia	60672	TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)
Canada	2817524	FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Lithuania	3310389
Austria	429922

Supplementary Protection Certificates for DUOBRII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	474	Finland
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	PA2013025	Lithuania		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	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506