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Profile for Tradename: AVODART

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Avodart is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eigthy-two patent family members in thirty-nine countries.

The generic ingredient in AVODART is dutasteride. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the dutasteride profile page.

Summary for Tradename: AVODART

Suppliers / Packagers: see list6

Pharmacology for Tradename: AVODART

Clinical Trials for: AVODART

Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
Status: Completed Condition: Prostate Cancer

ARTS - AVODART After Radical Therapy For Prostate Cancer Study
Status: Completed Condition: Neoplasms, Prostate; Prostate Cancer After a Radical Treatment

Bioequivalence - Duodart Against Avodart & Omnic
Status: Completed Condition: Prostatic Hyperplasia

Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.
Status: Completed Condition: Prostatic Hyperplasia

Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Status: Active, not recruiting Condition: Prostatic Hyperplasia

AVODART® Alopecia Post-marketing Surveillance (PMS)
Status: Completed Condition: Alopecia

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Status: Completed Condition: Benign Prostatic Hypertrophy

AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Status: Completed Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence

Courtesy of
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
CAPSULE;ORAL021319-001Nov 20, 2001RXYes5,565,467<disabled>YY <disabled>
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Paragraph IV activity for: AVODART

Drugname Dosage Strength RLD Submissiondate
dutasterideCapsules0.5 mgAvodart10/29/2007

Non-Orange Book Patents for Tradename: AVODART

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,817,818 Androstenones<disabled in preview>
5,977,126 Androstenones<disabled in preview>
5,846,976 Androstenone derivative<disabled in preview>
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International Patent Family for Tradename: AVODART

Country Document Number Publication Date
Germany69407422Jan 29, 1998
Slovakia34796Jul 03, 1996
Norway961080Mar 15, 1996
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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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