Deep knowledge on
small-molecule drugs and
the 90,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: AVODART

« Back to Dashboard
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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: AVODART

Country Document Number Publication Date
Germany10399022Jan 15, 2004
Iceland4206Mar 18, 1995
China1041939Feb 03, 1999
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a trial or see the database preview and plan comparison

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn