ARAZLO Drug Patent Profile

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When do Arazlo patents expire, and what generic alternatives are available?

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-seven 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 3^rd, 2017.

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Summary for ARAZLO

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	1
Patent Applications:	4,408
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for ARAZLO

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

Sponsor	Phase
Dr. Emmy Graber	Phase 4

See all ARAZLO clinical trials

Pharmacology for ARAZLO

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for ARAZLO

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

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

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Patent Expiration: ⤷ Sign Up

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Glossary

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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

Expired US Patents for ARAZLO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ARAZLO

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

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Country	Patent Number	Title	Estimated Expiration
China	1460013		⤷ Sign Up
Japan	2018526325	乾癬を治療するためのコルチコステロイドおよびレチノイドを含む局所用組成物	⤷ Sign Up
Spain	2326955		⤷ Sign Up
South Korea	20180053292	건선을 치료하기 위한 코르티코스테로이드 및 레티노이드를 포함하는 국소 조성물	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018209262		⤷ Sign Up
Brazil	112019023817	composições tópicas e métodos para o tratamento de doenças da pele	⤷ Sign Up
European Patent Office	1304992	SYSTEME TOPIQUE DE DISTRIBUTION DE GEL DESTINES AU TRAITEMENT DES TROUBLES DE LA PEAU (TOPICAL GEL DELIVERY SYSTEMS FOR TREATING SKIN DISORDERS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ARAZLO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2013025	Lithuania	⤷ Sign Up	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	SPC/GB13/061	United Kingdom	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	132013902214376	Italy	⤷ Sign Up	PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	2013C/060	Belgium	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description