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
Summary for DUOBRII
International Patents: | 53 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 6 |
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 |
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
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
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 |
---|---|---|---|
Brazil | 112017027332 | composições tópicas que compreendem um corticosteróide e um retinóide para tratar psoríase. | ⤷ Try a Trial |
Portugal | 2643002 | ⤷ Try a Trial | |
New Zealand | 610659 | Pharmaceutical formulations containing corticosteroids for topical administration | ⤷ Try a Trial |
Portugal | 1304992 | ⤷ 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 | 122013000081 | Germany | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
1304992 | 1390049-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
1304992 | C300617 | Netherlands | ⤷ Try a Trial | 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 | 132013902214376 | Italy | ⤷ Try a Trial | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |