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Serving 500+ biopharmaceutical companies globally:

Argus Health
Harvard Business School
Deloitte
Accenture
Dow
Merck
Covington
Cantor Fitzgerald
US Department of Justice
Boehringer Ingelheim

Generated: August 22, 2017

DrugPatentWatch Database Preview

ZYCLARA Drug Profile

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What is the patent landscape for Zyclara, and what generic Zyclara alternatives are available?

Zyclara is a drug marketed by Medicis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twenty patent family members in seventeen countries.

The generic ingredient in ZYCLARA is imiquimod. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for Tradename: ZYCLARA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list5
Patent Applications: see list5,567
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZYCLARA at DailyMed

Pharmacology for Tradename: ZYCLARA

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;TOPICAL022483-002Jul 15, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Medicis
ZYCLARA
imiquimod
CREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV activity for: ZYCLARA

Drugname Dosage Strength RLD Submissiondate
imiquimodCream3.75%Zyclara8/8/2012
imiquimodCream2.5%Zyclara6/17/2014

Non-Orange Book Patents for Tradename: ZYCLARA

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 Tradename: ZYCLARA

Country Document Number Estimated Expiration
Australia2009335943► Subscribe
Panama8855101► Subscribe
Dominican RepublicP2011000195► Subscribe
Eurasian Patent Organization201100984► Subscribe
Canada2649893► 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: ZYCLARA

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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Serving 500+ biopharmaceutical companies globally:

Chubb
Johnson and Johnson
McKinsey
Daiichi Sankyo
UBS
Citi
Colorcon
Moodys
Fish and Richardson
Dow

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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