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Last Updated: August 14, 2020

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IMIQUIMOD - Generic Drug Details

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What are the generic sources for imiquimod and what is the scope of patent protection?

Imiquimod is the generic ingredient in three branded drugs marketed by Bausch, Anda Repository, Apotex Inc, Cosette, Fougera Pharms, Glenmark Generics, Perrigo Israel, Strides Pharma, and Taro, and is included in ten NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has fifty-six patent family members in thirty countries.

There are fourteen drug master file entries for imiquimod. Six suppliers are listed for this compound.

Drug Prices for IMIQUIMOD

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Drug Sales Revenue Trends for IMIQUIMOD

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Recent Clinical Trials for IMIQUIMOD

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SponsorPhase
Dartmouth-Hitchcock Medical CenterEarly Phase 1
Assiut UniversityPhase 3
TheraclionPhase 1

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Pharmacology for IMIQUIMOD
Paragraph IV (Patent) Challenges for IMIQUIMOD
Tradename Dosage Ingredient NDA Submissiondate
ZYCLARA CREAM;TOPICAL imiquimod 022483 2014-06-17
ZYCLARA CREAM;TOPICAL imiquimod 022483 2012-08-08
ALDARA CREAM;TOPICAL imiquimod 020723 2006-10-17

US Patents and Regulatory Information for IMIQUIMOD

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 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fougera Pharms IMIQUIMOD imiquimod CREAM;TOPICAL 078548-001 Feb 25, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Anda Repository IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 AB RX No No   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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