➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
McKesson
Medtronic
McKinsey
Baxter

Last Updated: July 2, 2020

DrugPatentWatch Database Preview

DUOBRII Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for DUOBRII
Drug Prices for DUOBRII

See drug prices for DUOBRII

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

SponsorPhase
Ortho DermatologicsPhase 4
Psoriasis Treatment Center of Central New JerseyPhase 4

See all DUOBRII clinical trials

Pharmacology for DUOBRII

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
McKesson
Medtronic
McKinsey
Baxter

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.