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DUOBRII Drug Profile
» See Plans and Pricing
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 five patents protecting this drug.
This drug has seventy-four patent family members in twenty-seven 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 April 25, 2022. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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: | 74 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| 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 Generic Entry Opportunity Date for DUOBRII
Generic Entry Date for DUOBRII*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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 |
|---|---|
| Icahn School of Medicine at Mount Sinai | Phase 4 |
| Bausch Health Americas, Inc. | Phase 4 |
| Ortho Dermatologics | Phase 4 |
Pharmacology for DUOBRII
| Drug Class | Corticosteroid Retinoid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for DUOBRII
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUOBRII | LOTION;TOPICAL | halobetasol propionate; tazarotene | 209354 | 2020-06-11 |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Start Trial | ||||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DUOBRII
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2052714 | Start Trial |
| European Patent Office | 3621614 | Start Trial |
| Australia | 7900201 | Start Trial |
| South Korea | 20140043044 | Start Trial |
| Germany | 60138549 | Start Trial |
| China | 101305982 | Start Trial |
| Serbia | 60672 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUOBRII
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | 122013000081 | Germany | Start 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 | 2013C/060 | Belgium | Start Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1304992 | C300617 | Netherlands | Start 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 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 1304992 | PA2013025,C1304992 | Lithuania | Start 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 | CR 2013 00053 | Denmark | Start Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| 1304992 | 132013902214376 | Italy | Start 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 |
