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DUOBRII Drug Profile
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» See Plans and PricingWhen 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 sixty-three 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.
US ANDA Litigation and 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: | 63 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUOBRII |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 | Y | Start Trial | |||
| Bausch | DUOBRII | halobetasol propionate; tazarotene | LOTION;TOPICAL | 209354-001 | Apr 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
|---|---|---|
| Denmark | 2052714 | Start Trial |
| China | 108282998 | Start Trial |
| Australia | 2001279002 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUOBRII
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 92401 | Luxembourg | Start Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
