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

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Fish and Richardson
Medtronic
Deloitte
Cantor Fitzgerald
Covington
McKesson
Citi
AstraZeneca

Generated: February 25, 2018

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-two patent family members in seventeen countries.

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.
Summary for ZYCLARA
Drug patent expirations by year for ZYCLARA
Pharmacology for ZYCLARA

US Patents and Regulatory Information for 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;TOPICAL 022483-002 Jul 15, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

Paragraph IV (Patent) Challenges for ZYCLARA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Cream 3.75% ➤ Subscribe 8/8/2012
➤ Subscribe Cream 2.5% ➤ Subscribe 6/17/2014

Non-Orange Book US Patents for 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
9,370,509 2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod ➤ Sign Up
9,271,973 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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

International Patents for ZYCLARA

Supplementary Protection Certificates for ZYCLARA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/003 United Kingdom ➤ Sign Up PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Teva
Farmers Insurance
Mallinckrodt
Deloitte
Federal Trade Commission
Covington
Medtronic
Fish and Richardson

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.

botpot