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Last Updated: July 19, 2024

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, Apotex Inc, Cosette, Encube, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Strides Pharma, and Taro, and is included in eleven NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are fourteen drug master file entries for imiquimod. Eight 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
Northwestern UniversityEarly Phase 1
Assiut UniversityEarly Phase 1
VA Office of Research and DevelopmentPhase 3

See all imiquimod clinical trials

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
Encube IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Inc IMIQUIMOD imiquimod CREAM;TOPICAL 201994-001 Mar 6, 2012 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel IMIQUIMOD imiquimod CREAM;TOPICAL 078837-001 Sep 7, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch ALDARA imiquimod CREAM;TOPICAL 020723-001 Feb 27, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Viatris Healthcare Limited 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, nonhyperkeratotic, nonhypertrophic 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
Viatris Healthcare Limited 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
Canada 2649893 FORMULATIONS D'IMIQUIMOD A FAIBLE DOSE ET SCHEMA POSOLOGIQUEDE COURTE DUREE PERMETTANT DE TRAITER LA KERATOSE SENILE (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING ACTINIC KERATOSIS) ⤷  Sign Up
Dominican Republic P2012000007 FORMULACIONES DE IMIQUIMOD DE CONCENTRACION DE DOSIFICACION INFERIOR Y REGIMENES DE DOSIFICACION CORTOS PARA TRATAR VERRUGAS GENITALES Y PERIANALES ⤷  Sign Up
Mexico 2011001410 FORMULACIONES DE IMIQUIMOD DE CONCENTRACION DE DOSIFICACION INFERIOR Y REGIMENES DE DOSIFICACION CORTOS PARA TRATAR VERRUGAS GENITALES Y PERIANALES. (LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS.) ⤷  Sign Up
Peru 20110064 FORMULACIONES DE IMIQUIMOD DE 3,75% EN PESO ⤷  Sign Up
Israel 213628 פורמולציות של אימיקווימוד בעוצמה של מינון נמוך ומשטר מינוני קצר לטיפול בקרטוזיס אקטיני (Lower dosage strength imiquimod formulations and short dosing regimens for treating actinic keratosis) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2011008324 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for imiquimod

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0145340 SPC/GB99/003 United Kingdom ⤷  Sign Up 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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