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Last Updated: July 16, 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 patent protection?

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 three 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 Y   Start Trial
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-001 Sep 29, 2000 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
Taro Pharms TAZAROTENE tazarotene CREAM;TOPICAL 208258-001 Apr 3, 2017 AB RX 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
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997 RX Yes Yes   Start Trial   Start Trial   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 TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997   Start Trial   Start Trial
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 CREAM;TOPICAL 021184-002 Sep 29, 2000   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-001 Sep 29, 2000   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 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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
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
0031058 98C0008 Belgium   Start Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
1304992 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Medtronic
Harvard Business School
Mallinckrodt
McKesson

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.