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Last Updated: May 27, 2022

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 patent protection?

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

Halobetasol propionate; tazarotene has forty-two patent family members in twenty-one countries.

One supplier is listed for this compound.

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Taro Pharmaceuticals USAEarly Phase 1
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
Anatomical Therapeutic Chemical (ATC) Classes for halobetasol propionate; tazarotene
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE; TAZAROTENE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUOBRII Lotion halobetasol propionate; tazarotene 0.01%/0.045% 209354 1 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 halobetasol propionate; tazarotene

Country Patent Number Title Estimated Expiration
Portugal 3310389 See Plans and Pricing
South Korea 101967121 See Plans and Pricing
Serbia 60672 TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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