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Last Updated: April 18, 2021

DrugPatentWatch Database Preview

Halobetasol propionate; tazarotene - Generic Drug Details

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What are the generic sources for halobetasol propionate; tazarotene and what is the scope of freedom to operate?

Halobetasol propionate; tazarotene is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate; tazarotene has seventy-four patent family members in twenty-seven countries.

There are nine drug master file entries for halobetasol propionate; tazarotene. One supplier is listed for this compound.

Summary for halobetasol propionate; tazarotene
Recent Clinical Trials for halobetasol propionate; tazarotene

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SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 4
Bausch Health Americas, Inc.Phase 4

See all halobetasol propionate; tazarotene clinical trials

Pharmacology for halobetasol propionate; tazarotene
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE; TAZAROTENE
Tradename Dosage Ingredient NDA Submissiondate
DUOBRII LOTION;TOPICAL halobetasol propionate; tazarotene 209354 2020-06-11

US Patents and Regulatory Information for halobetasol propionate; tazarotene

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
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

Supplementary Protection Certificates for halobetasol propionate; tazarotene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 474 Finland   Start Trial
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 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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

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