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Last Updated: August 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209354

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NDA 209354 describes DUOBRII, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DUOBRII profile page.

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 209354
Tradename:DUOBRII
Applicant:Bausch
Ingredient:halobetasol propionate; tazarotene
Patents:5
Generic Entry Opportunity Date for 209354
Generic Entry Date for 209354*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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.

Pharmacology for NDA: 209354
Suppliers and Packaging for NDA: 209354
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354 NDA Bausch Health US, LLC 0187-0653 0187-0653-01 1 TUBE in 1 CARTON (0187-0653-01) > 100 g in 1 TUBE
DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354 NDA Bausch Health US, LLC 0187-0653 0187-0653-03 6 TUBE in 1 CARTON (0187-0653-03) > 3 g in 1 TUBE
Paragraph IV (Patent) Challenges for 209354
Tradename Dosage Ingredient NDA Submissiondate
DUOBRII LOTION;TOPICAL halobetasol propionate; tazarotene 209354 2020-06-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.01%;0.045%
Approval Date:Apr 25, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 25, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jun 6, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 6, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS

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Serving leading biopharmaceutical companies globally:

Moodys
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Boehringer Ingelheim
Merck
Baxter
Colorcon

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