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Imiquimod - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for imiquimod?

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.

This ingredient has twenty patent family members in seventeen countries.

There are thirteen drug master file entries for imiquimod. Eleven suppliers are listed for this compound.

Summary for Generic Name: imiquimod

Tradenames:3
Patents:6
Applicants:9
NDAs:10
Drug Master File Entries: see list13
Suppliers / Packagers: see list11
Bulk Api Vendors: see list86
Clinical Trials: see list41
Patent Applications: see list5,520
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc
IMIQUIMOD
imiquimod
CREAM;TOPICAL200481-001Apr 18, 2011RXNoNo► Subscribe► Subscribe
Strides Pharma
IMIQUIMOD
imiquimod
CREAM;TOPICAL202002-001Jun 24, 2014RXNoNo► Subscribe► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-002Jul 15, 2011RXYesYes8,222,270► Subscribe ► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes8,236,816► Subscribe ► Subscribe
Perrigo Israel
IMIQUIMOD
imiquimod
CREAM;TOPICAL078837-001Sep 7, 2010RXNoNo► 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, 19974,689,338*PED► Subscribe
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 19975,238,944*PED► 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
9,271,973Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy► Subscribe
9,370,5092.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod► 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
Uruguay32375► Subscribe
Israel213628► Subscribe
Ukraine110459► Subscribe
Costa Rica20110338► Subscribe
European Patent Office2378876► 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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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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