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Profile for Tradename: ALDARA

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Aldara is a drug marketed by Medicis and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

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

Summary for Tradename: ALDARA

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: ALDARA

Clinical Trials for: ALDARA

Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma
Status: Suspended Condition: Melanoma

Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratoses

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Status: Completed Condition: Port Wine Stain

Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Status: Completed Condition: Superficial Basal Cell Carcinoma

Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
Status: Recruiting Condition: Cervical Intraepithelial Neoplasia

Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses
Status: Recruiting Condition: Actinic Keratosis

Imiquimod Treatment of CIN Lesions
Status: Recruiting Condition: Cervical Intraepithelial Neoplasia

Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream
Status: Completed Condition: Actinic Keratosis

The Effects of Aldara as an Adjunct to Laser Treatment
Status: Completed Condition: Port Wine Stains

Bioequivalence Study of Two Imiquimod Cream 5%
Status: Completed Condition: Actinic Keratosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 1997RXYes7,696,159*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ALDARA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 19974,689,338*PED<disabled>
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 19975,238,944*PED<disabled>
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Paragraph IV activity for: ALDARA

Drugname Dosage Strength RLD Submissiondate
imiquimodCream5%Aldara10/17/2006
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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