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Last Updated: April 17, 2024

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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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-two 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 2, 2031. This may change due to patent challenges or generic licensing.

There have been four 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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DUOBRII
Generic Entry Date for DUOBRII*:
Constraining patent/regulatory exclusivity:
NDA:
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 DUOBRII

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

SponsorPhase
Dermatology Consulting Services, PLLCPhase 4
Icahn School of Medicine at Mount SinaiPhase 3
Bausch Health Americas, Inc.Phase 3

See all DUOBRII clinical trials

Pharmacology for DUOBRII
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 seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DUOBRII is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DUOBRII

Topical compositions and methods for treating psoriasis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Topical compositions and methods for treating psoriasis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS


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


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


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


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

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

International Patents for DUOBRII

When does loss-of-exclusivity occur for DUOBRII?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 11345240
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013012476
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 17524
Estimated Expiration: ⤷  Try a Trial

Patent: 55328
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3228281
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0230032
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 43002
Estimated Expiration: ⤷  Try a Trial

Patent: 33838
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 61270
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6398
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11007
Estimated Expiration: ⤷  Try a Trial

Patent: 13542990
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 43002
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6961
Estimated Expiration: ⤷  Try a Trial

Patent: 13005764
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0659
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 43002
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 43002
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 68598
Estimated Expiration: ⤷  Try a Trial

Patent: 13128607
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 43002
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1967121
Estimated Expiration: ⤷  Try a Trial

Patent: 140043044
Estimated Expiration: ⤷  Try a Trial

Patent: 180015281
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 35814
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Serbia 60672 TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016205001 ⤷  Try a Trial
Russian Federation 2013128607 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ ⤷  Try a Trial
New Zealand 610659 Pharmaceutical formulations containing corticosteroids for topical administration ⤷  Try a Trial
Hungary E061270 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUOBRII

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 92401 Luxembourg ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 474 Finland ⤷  Try a Trial
1304992 PA2013025,C1304992 Lithuania ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINUM + 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 C01304992/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.