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Last Updated: November 21, 2024

ARAZLO Drug Patent Profile


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Which patents cover Arazlo, and when can generic versions of Arazlo launch?

Arazlo is a drug marketed by Bausch and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Arazlo

A generic version of ARAZLO was approved as tazarotene by TARO on April 3rd, 2017.

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Summary for ARAZLO
International Patents:28
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 129
Clinical Trials: 1
Patent Applications: 4,416
Drug Prices: Drug price information for ARAZLO
What excipients (inactive ingredients) are in ARAZLO?ARAZLO excipients list
DailyMed Link:ARAZLO at DailyMed
Drug patent expirations by year for ARAZLO
Drug Prices for ARAZLO

See drug prices for ARAZLO

Recent Clinical Trials for ARAZLO

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

SponsorPhase
Dr. Emmy GraberPhase 4

See all ARAZLO clinical trials

Pharmacology for ARAZLO
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for ARAZLO
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 ARAZLO

ARAZLO is protected by two US patents.

Patents protecting ARAZLO

Topical compositions and methods for treating skin diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 9 YEARS OF AGE AND OLDER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ARAZLO

See the table below for patents covering ARAZLO around the world.

Country Patent Number Title Estimated Expiration
Japan 2004505900 ⤷  Sign Up
China 108282998 用于治疗银屑病的包含皮质类固醇和类视黄醇的局部组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS) ⤷  Sign Up
Argentina 030093 SISTEMA PARA LA DISTRIBUCION TOPICA DEL GEL ⤷  Sign Up
Portugal 1304992 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARAZLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 2013/044 Ireland ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania ⤷  Sign Up 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 1390049-3 Sweden ⤷  Sign Up PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992 CR 2013 00053 Denmark ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
>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.