duobrii Drug Patent Profile
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Which patents cover Duobrii, and when can generic versions of Duobrii launch?
Duobrii is a drug marketed by Bausch and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-four 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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Questions you can ask:
- What is the 5 year forecast for duobrii?
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Summary for duobrii
| International Patents: | 54 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for duobrii
*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
| Sponsor | Phase |
|---|---|
| Dermatology Consulting Services, PLLC | Phase 4 |
| Icahn School of Medicine at Mount Sinai | Phase 3 |
| Bausch Health Americas, Inc. | Phase 3 |
Pharmacology for duobrii
| Drug Class | Corticosteroid Retinoid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 ten US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of duobrii is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Topical compositions and methods for treating psoriasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical formulations containing corticosteroids for topical administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | 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 | ||||
| >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 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 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013012476
Patent: formulações farmacêuticas contendo corticosteróides para administração tópica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 17524
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 55328
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 3228281
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0230032
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 43002
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 33838
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 61270
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6398
Patent: פורמולציות רקחייות המכילות קורטיקוסטראוידים למתן על העור (Pharmaceutical formulations containing corticosteroids for topical administration)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 11007
Estimated Expiration: ⤷ Sign Up
Patent: 13542990
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 43002
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 6961
Patent: FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 13005764
Patent: FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0659
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 43002
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 43002
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 68598
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)
Estimated Expiration: ⤷ Sign Up
Patent: 13128607
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 43002
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1967121
Estimated Expiration: ⤷ Sign Up
Patent: 140043044
Patent: PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Patent: 180015281
Patent: 국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 35814
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 7900201 | ⤷ 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 |
| Mexico | 346961 | FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.) | ⤷ Sign Up |
| Slovenia | 2052714 | ⤷ Sign Up | |
| European Patent Office | 4233838 | FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) | ⤷ Sign Up |
| Canada | 2817524 | FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION) | ⤷ Sign Up |
| Germany | 60138549 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for duobrii
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | 474 | Finland | ⤷ Sign Up | |
| 1304992 | CR 2013 00053 | Denmark | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| 1304992 | C300617 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322 |
| 1304992 | 122013000081 | Germany | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
| 1304992 | SPC/GB13/061 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| 1304992 | 2013C/060 | Belgium | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1304992 | 92401 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| >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.
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