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Details for Generic Name: dutasteride; tamsulosin hydrochloride

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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.

This ingredient has eigthy-one patent family members in thirty-eight countries.

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

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list15
Suppliers / Packaging: see list4
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: Completed Condition: Prostatic Hyperplasia

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Status: Completed 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 ClinicalTrials.org
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
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467<disabled>YY<disabled>
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: dutasteride; tamsulosin hydrochloride

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9507927Mar 23, 1995
European Patent Office0719277Dec 17, 1997
Czech Republic286069Jan 12, 2000
Germany10399022Jan 15, 2004
Luxembourg91027Apr 28, 2004
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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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