ARAZLO Drug Patent Profile

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-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.

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

See drug prices 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

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
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019		RX	Yes	Yes			Y

Expired US Patents for ARAZLO

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

International Patents for ARAZLO

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

Country	Patent Number	Title	Estimated Expiration
Japan	7410720
Hungary	E050603
Hong Kong	1125847
European Patent Office	3310389	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE ET UN RÉTINOÏDE POUR LE TRAITEMENT DU PSORIASIS (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)
South Korea	100840169
Brazil	112019023817	composições tópicas e métodos para o tratamento de doenças da pele
World Intellectual Property Organization (WIPO)	2018209262

Supplementary Protection Certificates for ARAZLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	PA2013025	Lithuania		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	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	474	Finland