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Last Updated: August 12, 2020

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate; tazarotene has sixty-five patent family members in twenty-three countries.

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

Summary for halobetasol propionate; tazarotene
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   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 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 C300617 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992 474 Finland   Start Trial
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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