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Last Updated: September 26, 2020

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TAZAROTENE - Generic Drug Details

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

Tazarotene is the generic ingredient in five branded drugs marketed by Mayne Pharma, Allergan, Cosette, Fougera Pharms Inc, Taro Pharms, and Bausch, and is included in seven NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has fifty-eight patent family members in twenty-six countries.

There are eight drug master file entries for tazarotene. Nine suppliers are listed for this compound.

Drug Prices for TAZAROTENE

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Recent Clinical Trials for TAZAROTENE

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

SponsorPhase
Dana-Farber Cancer InstitutePhase 2
Assiut UniversityPhase 4
Dr. Reddy's Laboratories LimitedPhase 2

See all TAZAROTENE clinical trials

Pharmacology for TAZAROTENE
Drug ClassRetinoid

US Patents and Regulatory Information for TAZAROTENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma FABIOR tazarotene AEROSOL, FOAM;TOPICAL 202428-001 May 11, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fougera Pharms Inc TAZAROTENE tazarotene CREAM;TOPICAL 211175-001 Jan 28, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma FABIOR tazarotene AEROSOL, FOAM;TOPICAL 202428-001 May 11, 2012 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

Expired US Patents for TAZAROTENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan AVAGE tazarotene CREAM;TOPICAL 021184-003 Sep 30, 2002   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TAZAROTENE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0284288 SPC/GB98/002 United Kingdom   Start Trial PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
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
1304992 1390049-3 Sweden   Start Trial PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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