You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

IMIQUIMOD Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


DrugPatentWatch® Litigation and Generic Entry Outlook for Imiquimod

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

  Try a Trial

Drug patent expirations by year for IMIQUIMOD
Drug Prices for IMIQUIMOD

See drug prices for IMIQUIMOD

Drug Sales Revenue Trends for IMIQUIMOD

See drug sales revenues for IMIQUIMOD

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
Apotex Inc IMIQUIMOD imiquimod CREAM;TOPICAL 091308-001 Apr 6, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma IMIQUIMOD imiquimod CREAM;TOPICAL 202002-001 Jun 24, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms IMIQUIMOD imiquimod CREAM;TOPICAL 078548-001 Feb 25, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro IMIQUIMOD imiquimod CREAM;TOPICAL 205971-001 Jan 26, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.