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Last Updated: March 18, 2024

HALOBETASOL PROPIONATE; TAZAROTENE - Generic Drug Details


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What are the generic drug 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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for HALOBETASOL PROPIONATE; TAZAROTENE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for HALOBETASOL PROPIONATE; TAZAROTENE
Generic Entry Date for HALOBETASOL PROPIONATE; TAZAROTENE*:
Constraining patent/regulatory exclusivity:
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 HALOBETASOL PROPIONATE; TAZAROTENE

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

SponsorPhase
Taro Pharmaceuticals USAEarly Phase 1
Bausch Health Americas, Inc.Phase 4
Icahn School of Medicine at Mount SinaiPhase 4

See all HALOBETASOL PROPIONATE; TAZAROTENE clinical trials

Pharmacology 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.