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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:2
Applicants:1
NDAs:1
Suppliers: see list2

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

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: Not yet 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

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

Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Status: Recruiting Condition: Actinic Keratoses

Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Status: Recruiting Condition: Paget Disease, Extramammary

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
3m
ALDARA
imiquimod
Cream; Topical020723-001FEB 27, 1997RXYes4,689,338<disabled><disabled>
3m
ALDARA
imiquimod
Cream; Topical020723-001FEB 27, 1997RXYes5,238,944<disabled><disabled>
3m
ALDARA
imiquimod
Cream; Topical020723-001FEB 27, 1997RXYes<disabled><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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