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Generated: October 24, 2017

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Tazarotene - Generic Drug Details

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What are the generic sources for tazarotene and what is the scope of tazarotene patent protection?

Tazarotene
is the generic ingredient in four branded drugs marketed by Allergan, Mayne Pharma, and Taro, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has thirty-five patent family members in sixteen countries and three supplementary protection certificates in three countries.

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

Summary for Generic Name: tazarotene

US Patents:1
Tradenames:4
Applicants:3
NDAs:4
Drug Master File Entries: see list8
Suppliers / Packagers: see list6
Bulk Api Vendors: see list81
Clinical Trials: see list36
Patent Applications: see list5,259
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tazarotene at DailyMed

Pharmacology for Ingredient: tazarotene

Ingredient-typeRetinoids
Drug ClassRetinoid
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
GEL;TOPICAL020600-001Jun 13, 1997RXYesYes► Subscribe► Subscribe► Subscribe
Taro
TAZAROTENE
tazarotene
CREAM;TOPICAL208258-001Apr 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
CREAM;TOPICAL021184-002Sep 29, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Mayne Pharma
FABIOR
tazarotene
AEROSOL, FOAM;TOPICAL202428-001May 11, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Allergan
AVAGE
tazarotene
CREAM;TOPICAL021184-003Sep 30, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 1997RXYesYes► Subscribe► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
CREAM;TOPICAL021184-001Sep 29, 2000RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tazarotene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-001Jun 13, 1997► Subscribe► Subscribe
Allergan
AVAGE
tazarotene
CREAM;TOPICAL021184-003Sep 30, 2002► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 1997► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-001Jun 13, 1997► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 1997► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
CREAM;TOPICAL021184-001Sep 29, 2000► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-001Jun 13, 1997► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 1997► Subscribe► Subscribe
Allergan
TAZORAC
tazarotene
CREAM;TOPICAL021184-002Sep 29, 2000► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tazarotene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,991,390Inhalation device and method► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tazarotene

Country Document Number Estimated Expiration
South Korea20110138353► Subscribe
Israel214520► Subscribe
World Intellectual Property Organization (WIPO)2011085022► Subscribe
Australia2010217190► Subscribe
Japan2016165510► Subscribe
Japan2013516283► Subscribe
BrazilPI1008037► Subscribe
Taiwan201143823► Subscribe
Japan6182191► Subscribe
China105381524► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TAZAROTENE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0008Belgium► SubscribePRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
/1998Austria► SubscribePRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
C/GB98/002United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Covington
Boehringer Ingelheim
Merck
Colorcon
Johnson and Johnson
Mallinckrodt
Chubb
Accenture
Cerilliant

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 verifification 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.

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