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Last Updated: May 27, 2022

DUOBRII Drug Patent Profile


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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

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Drug patent expirations by year for DUOBRII
Drug Prices for DUOBRII

See drug prices for DUOBRII

Recent Clinical Trials for DUOBRII

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

SponsorPhase
Austin Institute for Clinical ResearchPhase 3
OrthoDermatologicsPhase 3
Taro Pharmaceuticals USAEarly Phase 1

See all DUOBRII clinical trials

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

Topical compositions and methods for treating psoriasis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for treating psoriasis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DUOBRII

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DUOBRII

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

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

Supplementary Protection Certificates for DUOBRII

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

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