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Last Updated: March 19, 2024

ALDARA Drug Patent Profile


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Which patents cover Aldara, and when can generic versions of Aldara launch?

Aldara is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in ALDARA is imiquimod. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aldara

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

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Summary for ALDARA
Drug patent expirations by year for ALDARA
Drug Prices for ALDARA

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Recent Clinical Trials for ALDARA

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

SponsorPhase
Leiden University Medical CenterEarly Phase 1
German Cancer AidPhase 1
Roche Pharma AGPhase 1

See all ALDARA clinical trials

Pharmacology for ALDARA
Paragraph IV (Patent) Challenges for ALDARA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ALDARA Cream imiquimod 5% 020723 1 2006-10-17

US Patents and Regulatory Information for ALDARA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ALDARA imiquimod CREAM;TOPICAL 020723-001 Feb 27, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 ALDARA

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 ALDARA

See the table below for patents covering ALDARA around the world.

Country Patent Number Title Estimated Expiration
Norway 165146 ⤷  Try a Trial
Hong Kong 1006275 ⤷  Try a Trial
Netherlands 980042 ⤷  Try a Trial
European Patent Office 0310950 QUINOLINE INTERMEDIATES FOR THE SYNTHESIS OF 1H-IMIDAZO(4,5-C)QUINOLINES AND 1H-IMIDAZO(4,5-C)QUINOLIN-4-AMIMES ⤷  Try a Trial
Australia 631585 ⤷  Try a Trial
Denmark 164452 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALDARA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0145340 99C0005 Belgium ⤷  Try a Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0145340 SPC/GB99/003 United Kingdom ⤷  Try a 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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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.