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
Russian Federation	2251410	СИСТЕМА ДОСТАВКИ В ВИДЕ ГЕЛЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ (DELIVERY SYSTEM IN THE FORM OF GEL FOR LOCAL APPLICATION)
South Korea	102643849
Slovenia	1304992
World Intellectual Property Organization (WIPO)	0211683
Denmark	1304992

Supplementary Protection Certificates for ARAZLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0284288	12/1998	Austria		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		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
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