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Last Updated: March 19, 2024

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, Padagis Israel, Solaris Pharma Corp, and Bausch, and is included in eleven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has forty-nine patent family members in twenty-four countries.

There are eight drug master file entries for tazarotene. Eleven 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
Dermatology Consulting Services, PLLCPhase 4
Ortho DermatologicsPhase 4
Zagazig UniversityPhase 2

See all TAZAROTENE clinical trials

Pharmacology for TAZAROTENE
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for TAZAROTENE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ARAZLO Topical Lotion tazarotene 0.045% 211882 1 2022-05-12

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
Cosette TAZAROTENE tazarotene GEL;TOPICAL 215433-001 Sep 13, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-002 Sep 29, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-001 Sep 29, 2000 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

Expired US Patents for TAZAROTENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997 ⤷  Try a Trial ⤷  Try a Trial
Allergan AVAGE tazarotene CREAM;TOPICAL 021184-003 Sep 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997 ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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
0031058 98C0008 Belgium ⤷  Try a Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288 12/1998 Austria ⤷  Try a Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.