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Last Updated: October 1, 2022

ALDARA Drug Patent Profile


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When do Aldara patents expire, and what generic alternatives are available?

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. Seven 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

See drug prices for ALDARA

Recent Clinical Trials for ALDARA

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

SponsorPhase
Leiden University Medical CenterEarly Phase 1
German Cancer Research CenterPhase 1
German Cancer AidPhase 1

See all ALDARA clinical trials

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 ALDARA

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 ALDARA

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

Country Patent Number Title Estimated Expiration
Canada 2004597 FORMULES TOPIQUES ET SYSTEMES DE DISPENSATION TRANSDERMIQUE CONTENANT DE LA 1-ISOBUTYL-1H-IMIDAZO [4,5-C]QUINOLINE-4-AMINE (TOPICAL FORMULATIONS AND TRANSDERMAL DELIVERY SYSTEMS CONTAINING 1-ISOBUTYL-1H-IMIDAZO-[4,5-C]QUINOLINE-4-AMINE) See Plans and Pricing
Hong Kong 1006275 See Plans and Pricing
Denmark 176121 See Plans and Pricing
Austria 84525 See Plans and Pricing
Japan H02282327 TOPOGRAPHIC COMPOSITION CONTAINING 1-ISOBUTYL-1H- IMIDAZO(4,5-C) QUINOLINE-4-AMINE, AND DIADERMICALLY ABSORBED MEDICATION SYSTEM See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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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