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Details for Generic Name: dutasteride

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Dutasteride is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Barr, and Anchen Pharms, and is included in four 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-two patent family members in thirty-nine countries.

There are fifteen drug master file entries for dutasteride. Three suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: dutasteride

Drug Master File Entries: see list15
Suppliers / Packaging: see list6
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: dutasteride

Tentative approvals for DUTASTERIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL0.5MG

Clinical Trials for: dutasteride

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

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

Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Status: Completed Condition: Hypogonadism; Hypogonadism, Male

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Status: Completed Condition: Androgenetic Alopecia

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

TRADE-Testosterone Replacement and Dutasteride Effectiveness
Status: Completed Condition: Hypogonadism; Benign 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
CAPSULE;ORAL090095-001Dec 21, 2010RXNo<disabled><disabled>
Anchen Pharms
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467<disabled>YY <disabled>
CAPSULE;ORAL021319-001Nov 20, 2001RXYes5,565,467<disabled>YY <disabled>
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International Patent Family for Ingredient: dutasteride

Country Document Number Publication Date
Iceland4205Mar 18, 1995
Germany69407978Feb 19, 1998
CroatiaP940563Feb 28, 1997
Canada2170047Mar 23, 1995
Norway961085Apr 22, 1996
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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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