Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: dutasteride; tamsulosin hydrochloride

« Back to Dashboard
Dutasteride; tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Anchen Pharms and Glaxosmithkline, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for dutasteride; tamsulosin hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: dutasteride; tamsulosin hydrochloride

Drug Master File Entries: see list15
Suppliers: see list2
Formulation / Manufacturing:see details

Pharmacology for Ingredient: dutasteride; tamsulosin hydrochloride

Clinical Trials for: dutasteride; tamsulosin hydrochloride

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

A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
Status: Completed Condition: Prostatic Hyperplasia

A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
Status: Completed Condition: Prostatic Hyperplasia

Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States
Status: Active, not recruiting Condition: Prostatic Hyperplasia

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Status: Recruiting Condition: Urologic Diseases

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State
Status: Completed Condition: Urologic Diseases

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

This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples
Status: Completed Condition: Prostatic Hyperplasia

Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
Status: Completed Condition: Benign Prostatic Hyperplasia

Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Status: Recruiting Condition: Prostatic Hyperplasia

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
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467<disabled>YY<disabled>
Anchen Pharms
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a free 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 free trial or see the 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