TAZAROTENE - Generic Drug Details

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What are the generic drug sources for tazarotene and what is the scope of freedom to operate?

Tazarotene is the generic ingredient in five branded drugs marketed by Mayne Pharma, Allergan, Cosette, Fougera Pharms Inc, Padagis Israel, Taro, Solaris Pharma Corp, and Bausch, and is included in twelve NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has fifty-two patent family members in twenty-four countries.

There are eight drug master file entries for tazarotene. Eleven suppliers are listed for this compound.

Summary for TAZAROTENE

International Patents:	52
US Patents:	5
Tradenames:	5
Applicants:	8
NDAs:	12
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	53
Patent Applications:	6,684
Drug Prices:	Drug price trends for TAZAROTENE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAZAROTENE
What excipients (inactive ingredients) are in TAZAROTENE?	TAZAROTENE excipients list
DailyMed Link:	TAZAROTENE at DailyMed

See drug prices for TAZAROTENE

Recent Clinical Trials for TAZAROTENE

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

Sponsor	Phase
Ortho Dermatologics	Phase 4
Dermatology Consulting Services, PLLC	Phase 4
Zagazig University	Phase 2

See all TAZAROTENE clinical trials

Pharmacology for TAZAROTENE

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for TAZAROTENE

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

Paragraph IV (Patent) Challenges for TAZAROTENE

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 TAZAROTENE

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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
Allergan	TAZORAC	tazarotene	CREAM;TOPICAL	021184-002	Sep 29, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	TAZORAC	tazarotene	CREAM;TOPICAL	021184-001	Sep 29, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms Inc	TAZAROTENE	tazarotene	CREAM;TOPICAL	211175-001	Jan 28, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	TAZAROTENE	tazarotene	CREAM;TOPICAL	208258-001	Apr 3, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 TAZAROTENE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	⤷ Sign Up	⤷ Sign Up
Allergan	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	⤷ Sign Up	⤷ Sign Up
Allergan	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	⤷ Sign Up	⤷ Sign Up
Allergan	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TAZAROTENE

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Country	Patent Number	Title	Estimated Expiration
Denmark	2400951		⤷ Sign Up
Spain	2812451		⤷ Sign Up
European Patent Office	2400951		⤷ Sign Up
Serbia	60672	TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TAZAROTENE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0284288	SPC/GB98/002	United Kingdom	⤷ Sign Up	PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0284288	12/1998	Austria	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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