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Last Updated: May 29, 2023

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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in eighteen countries.

The generic ingredient in ARAZLO is tazarotene. There are eight drug master file entries for this compound. Eight 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 PHARMS on April 3rd, 2017.

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Summary for ARAZLO
Drug patent expirations by year for ARAZLO
Drug Prices for ARAZLO

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Recent Clinical Trials for ARAZLO

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Dr. Emmy GraberPhase 4

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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 one US patents and one FDA Regulatory Exclusivity.

Patents protecting ARAZLO

Topical compositions and methods for treating skin diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ARAZLO

Exclusivity Expiration: ⤷  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
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ARAZLO tazarotene LOTION;TOPICAL 211882-001 Dec 18, 2019 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

International Patents for ARAZLO

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

Country Patent Number Title Estimated Expiration
Hungary E050603 ⤷  Try a Trial
Denmark 1304992 ⤷  Try a Trial
Denmark 3310389 ⤷  Try a Trial
South Africa 200301037 Topical gel delivery system. ⤷  Try a Trial
Brazil 112017027332 composições tópicas que compreendem um corticosteróide e um retinóide para tratar psoríase. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARAZLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 132013902214376 Italy ⤷  Try a Trial PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 2013/044 Ireland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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
0031058 98C0008 Belgium ⤷  Try a Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
1304992 CR 2013 00053 Denmark ⤷  Try a Trial 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.