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Last Updated: April 15, 2021

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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 freedom to operate?

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-seven patent family members in thirty-one 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical University of GrazPhase 4
Nova Scotia Health AuthorityPhase 4
Nepal Health Research CouncilN/A

See all imiquimod clinical trials

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
Bausch ALDARA imiquimod CREAM;TOPICAL 020723-001 Feb 27, 1997 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
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
Glenmark Generics IMIQUIMOD imiquimod CREAM;TOPICAL 201994-001 Mar 6, 2012 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for imiquimod

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0145340 SPC/GB99/003 United Kingdom   Start Trial PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Express Scripts
Harvard Business School
McKinsey
Boehringer Ingelheim

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