Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
US Army
Moodys
Citi
AstraZeneca
Harvard Business School
Healthtrust
Novartis
Queensland Health
Medtronic

Generated: December 11, 2017

DrugPatentWatch Database Preview

ZYCLARA Drug Profile

« Back to Dashboard

When do Zyclara patents expire, and what generic 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-one patent family members in seventeen countries and one supplementary protection certificate in one country.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
MedicisZYCLARAimiquimodCREAM;TOPICAL022483-002Jul 15, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MedicisZYCLARAimiquimodCREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MedicisZYCLARAimiquimodCREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MedicisZYCLARAimiquimodCREAM;TOPICAL022483-001Mar 25, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: ZYCLARA

Country Document Number Estimated Expiration
TaiwanI442923► Subscribe
Peru04692010► Subscribe
Argentina074802► Subscribe
Eurasian Patent Organization201100984► Subscribe
Peru23672014► Subscribe
Israel213628► Subscribe
Mexico346455► Subscribe
Taiwan201040173► Subscribe
Colombia6400171► Subscribe
Panama8855101► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Harvard Business School
Baxter
UBS
US Department of Justice
Citi
Colorcon
Cantor Fitzgerald
Express Scripts

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot