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Last Updated: January 30, 2023

Imiquimod - Generic Drug Details


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What are the generic drug 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, Padagis Israel, Strides Pharma, and Taro, and is included in eleven NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has fifty-nine patent family members in thirty-one countries.

There are fourteen drug master file entries for imiquimod. Nine 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
VA Office of Research and DevelopmentPhase 3
Leiden University Medical CenterEarly Phase 1
Assiut UniversityN/A

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Pharmacology for imiquimod
Paragraph IV (Patent) Challenges for IMIQUIMOD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYCLARA Cream imiquimod 2.5% 022483 1 2014-06-17
ZYCLARA Cream imiquimod 3.75% 022483 1 2012-08-08
ALDARA Cream imiquimod 5% 020723 1 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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc IMIQUIMOD imiquimod CREAM;TOPICAL 091308-001 Apr 6, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for imiquimod

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Meda AB Aldara imiquimod EMEA/H/C/000179
Imiquimod cream is indicated for the topical treatment of:external genital and perianal warts (condylomata acuminata) in adults;small superficial basal-cell carcinomas (sBCCs) in adults;clinically typical, non-hyperkeratotic, non-hypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and / or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Authorised no no no 1998-09-18
Meda AB Zyclara imiquimod EMEA/H/C/002387
Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Authorised no no no 2012-08-23
Laboratoires 3M Santé Zartra imiquimod EMEA/H/C/000180
Imiquimod cream is indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.
Withdrawn no no no 1998-09-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for imiquimod

Country Patent Number Title Estimated Expiration
Spain 2720149 See Plans and Pricing
Lithuania 2378876 See Plans and Pricing
Dominican Republic P2011000195 FORMULACIONES DE IMIQUIMOD DE BAJA CONCENTRACION DE DOSIS Y REGIMENES DE DOSIS DE CORTA DURACION PARA TRATAR QUERATOSIS ACTINICA See Plans and Pricing
Poland 2378876 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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