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Serving leading biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
McKesson
Cipla
US Army
Colorcon
Deloitte
Moodys
Novartis
US Department of Justice

Generated: October 18, 2017

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Imiquimod - Generic Drug Details

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

Imiquimod
is the generic ingredient in three branded drugs marketed by Strides Pharma, Apotex Inc, Medicis, Perrigo Israel, Tolmar, Fougera Pharms, Taro, G And W Labs Inc, and Glenmark Generics, and is included in ten NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has twenty-one patent family members in seventeen countries and one supplementary protection certificate in one country.

There are fourteen drug master file entries for imiquimod. Ten suppliers are listed for this compound.

Summary for Generic Name: imiquimod

US Patents:5
Tradenames:3
Applicants:9
NDAs:10
Drug Master File Entries: see list14
Suppliers / Packagers: see list10
Bulk Api Vendors: see list86
Clinical Trials: see list124
Patent Applications: see list5,808
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:imiquimod at DailyMed

Pharmacology for Ingredient: imiquimod

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
G And W Labs Inc
IMIQUIMOD
imiquimod
CREAM;TOPICAL200481-001Apr 18, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
IMIQUIMOD
imiquimod
CREAM;TOPICAL091308-001Apr 6, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Generics
IMIQUIMOD
imiquimod
CREAM;TOPICAL201994-001Mar 6, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Fougera Pharms
IMIQUIMOD
imiquimod
CREAM;TOPICAL078548-001Feb 25, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro
IMIQUIMOD
imiquimod
CREAM;TOPICAL200173-001Apr 15, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 1997ABRXYesYes► Subscribe► SubscribeY► Subscribe
Perrigo Israel
IMIQUIMOD
imiquimod
CREAM;TOPICAL078837-001Sep 7, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Strides Pharma
IMIQUIMOD
imiquimod
CREAM;TOPICAL202002-001Jun 24, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: imiquimod

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 1997► Subscribe► Subscribe
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: imiquimod

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
9,370,5092.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod► Subscribe
9,271,973Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy► 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: imiquimod

Country Document Number Estimated Expiration
Eurasian Patent Organization201100984► Subscribe
Costa Rica20110338► Subscribe
Mexico346455► Subscribe
Peru04692010► Subscribe
TaiwanI442923► Subscribe
Australia2009335943► Subscribe
Taiwan201040173► Subscribe
Uruguay32375► Subscribe
Mexico2011001555► Subscribe
Canada2709732► 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: IMIQUIMOD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/003United Kingdom► SubscribePRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
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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
Baxter
McKesson
Harvard Business School
Novartis
Citi
Covington
Chubb
AstraZeneca
Healthtrust

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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