DrugPatentWatch Database Preview
DUOBRII Drug Profile
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 four patents protecting this drug.
This drug has sixty-one patent family members in twenty-three 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.
Summary for DUOBRII
| International Patents: | 61 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUOBRII |
| DailyMed Link: | DUOBRII at DailyMed |
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 |
|---|---|
| Ortho Dermatologics | Phase 4 |
| Psoriasis Treatment Center of Central New Jersey | Phase 4 |
Pharmacology for DUOBRII
| Drug Class | Corticosteroid Retinoid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 | 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 | |||
| 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 |
International Patents for DUOBRII
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0211683 | Start Trial |
| Russian Federation | 2251410 | Start Trial |
| South Korea | 20140043044 | Start Trial |
| South Korea | 20030057526 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUOBRII
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 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 | 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 | PA2013025 | Lithuania | Start 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 |
