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Last Updated: October 26, 2021

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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 eight 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. Seven 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
Central Hospital, Nancy, FrancePhase 2
Columbia UniversityEarly Phase 1
BayerPhase 1

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 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Anda Repository IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for imiquimod

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ALDARA imiquimod CREAM;TOPICAL 020723-001 Feb 27, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch ALDARA imiquimod CREAM;TOPICAL 020723-001 Feb 27, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Medtronic
AstraZeneca
McKinsey
McKesson

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.