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Last Updated: August 5, 2020

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IMIQUIMOD Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Imiquimod

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

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Drug patent expirations by year for IMIQUIMOD
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
Anda Repository IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma IMIQUIMOD imiquimod CREAM;TOPICAL 202002-001 Jun 24, 2014 DISCN No No   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
Taro IMIQUIMOD imiquimod CREAM;TOPICAL 200173-001 Apr 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc IMIQUIMOD imiquimod CREAM;TOPICAL 091308-001 Apr 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Cosette IMIQUIMOD imiquimod CREAM;TOPICAL 200481-001 Apr 18, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo Israel IMIQUIMOD imiquimod CREAM;TOPICAL 078837-001 Sep 7, 2010 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Express Scripts
Moodys
Medtronic
AstraZeneca

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