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Last Updated: July 7, 2020

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ZYCLARA Drug Profile


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Which patents cover Zyclara, and when can generic versions of Zyclara launch?

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

This drug has fifty-six patent family members in thirty countries.

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

US ANDA Litigation and Generic Entry Outlook for Zyclara

A generic version of ZYCLARA was approved as imiquimod by FOUGERA PHARMS on February 25th, 2010.

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Drug patent expirations by year for ZYCLARA
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Drug Sales Revenue Trends for ZYCLARA

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Recent Clinical Trials for ZYCLARA

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SponsorPhase
Aalborg UniversityN/A
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1

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Pharmacology for ZYCLARA
Paragraph IV (Patent) Challenges for ZYCLARA
Tradename Dosage Ingredient NDA Submissiondate
ZYCLARA CREAM;TOPICAL imiquimod 022483 2014-06-17
ZYCLARA CREAM;TOPICAL imiquimod 022483 2012-08-08

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
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-002 Jul 15, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Express Scripts
AstraZeneca
Baxter
McKesson

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