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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 is one tentative approval 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)

Pharmacology for Ingredient: dutasteride

Tentative approvals for DUTASTERIDE

Applicant Application No. Form Dosage

Clinical Trials for: dutasteride

Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Status: Active, not recruiting Condition: Prostatic Hyperplasia

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

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
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467<disabled>YY <disabled>
CAPSULE;ORAL090095-001Dec 21, 2010RXNo<disabled><disabled>
Anchen Pharms
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: dutasteride

Country Document Number Publication Date
Germany69407422Jan 29, 1998
Slovakia34796Jul 03, 1996
Norway961080Mar 15, 1996
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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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