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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.

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 are seven tentative approvals for this compound. Additional details are available on the dutasteride profile page.

Summary for Tradename: AVODART

Suppliers: see list3

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

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

Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Status: Completed Condition: Alcohol Related Disorders; Alcoholism; Alcohol Abuse

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
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Preferred citation:

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

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