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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, Actavis Labs Fl Inc, Amneal Pharms, Apotex Inc, Banner Pharmacaps, Barr, Breckenridge Pharm, Rising Pharms Inc, Roxane, Sandoz Inc, Strides Arcolab Ltd, Vintage Pharms Llc, and Anchen Pharms, and is included in fifteen 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 sixteen drug master file entries for dutasteride. Three suppliers are listed for this compound.

Summary for Generic Name: dutasteride

Tradenames:4
Patents:1
Applicants:13
NDAs:15
Drug Master File Entries: see list16
Suppliers / Packaging: see list6
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)

Pharmacology for Ingredient: dutasteride

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

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

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

Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Status: Completed Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence

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

Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Status: Completed Condition: Alcohol Related Disorders; Alcoholism; Alcohol Abuse

AVODART® Alopecia Post-marketing Surveillance (PMS)
Status: Completed Condition: Alopecia

Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
Status: Completed Condition: Prostatic Hyperplasia

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

MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
Status: Completed Condition: Nonmalignant Neoplasm; Prostate Cancer

Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Status: Completed Condition: Benign Prostatic Hypertrophy

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

Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer
Status: Completed Condition: Prostate Cancer; Castration-resistant, Metastatic

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

28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Status: Completed Condition: Hypogonadism; Hypogonadism, Male

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Status: Completed Condition: Prostate Cancer

Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
Status: Active, not recruiting Condition: Prostate Cancer; Erectile Dysfunction; Lower Urinary Tract Symptoms

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia
Status: Active, not recruiting Condition: Alopecia

Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)
Status: Completed Condition: Kennedy's Disease; Spinal and Bulbar Muscular Atrophy

Oral Androgens in Man-4: (Short Title: Oral T-4)
Status: Completed Condition: Contraception

Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers
Status: Completed Condition: Alopecia

Response of Patients on Surveillance for Prostate Cancer to Dutasteride
Status: Completed Condition: Prostate Cancer

Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
Status: Completed Condition: Neoplasms, Prostate; Prostate Cancer

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia
Status: Completed Condition: Alopecia; Androgenetic Alopecia

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
Status: Completed Condition: Alopecia

Dutasteride Treatment for the Reduction of Heavy Drinking in Men
Status: Recruiting Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence

Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Status: Recruiting Condition: Prostate Cancer

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Status: Completed Condition: Benign Prostatic Hyperplasia (BPH)

Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Status: Completed Condition: Prostate Cancer

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

ARTS - AVODART After Radical Therapy For Prostate Cancer Study
Status: Completed Condition: Neoplasms, Prostate; Prostate Cancer After a Radical Treatment

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

Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects
Status: Completed Condition: Prostatic Hyperplasia

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

STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
Status: Withdrawn Condition: Adenocarcinoma of the Prostate

Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
Status: Completed Condition: Hypogonadism

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Status: Completed Condition: Prostate Cancer

Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
Status: Completed Condition: Benign Prostatic Hyperplasia

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
Status: Completed Condition: Benign Prostatic Hyperplasia

AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Pharmacogenetics of Alcohol: Treatment Implications
Status: Completed Condition: Alcohol Related Disorders; Alcoholism; Alcohol Abuse

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
Status: Completed Condition: Prostatic Hyperplasia

Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction
Status: Completed Condition: Benign Prostatic Hyperplasia

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia
Status: Active, not recruiting Condition: Prostatic Hyperplasia

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

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
Status: Completed Condition: Prostatic Hyperplasia

Safety and Pharmacokinetic Characteristics of DKF-313
Status: Recruiting Condition: Benign Prostate Hyperplasia; Healthy

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
Status: Completed Condition: Prostatic Hyperplasia

ITT-5 Mechanisms of Spermatogenesis
Status: Not yet recruiting Condition: Gonadotropin Deficiency

A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
Status: Terminated Condition: Benign Prostatic Hyperplasia

Enzalutamide & Dutasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.
Status: Recruiting Condition: Prostate Cancer

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy
Status: Withdrawn Condition: Prostate Cancer; Localized Prostate Cancer

Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Dutasteride to Treat Women With Menstrually Related Mood Disorders
Status: Completed Condition: Premenstrual Syndrome; PMS; Healthy; Depression

Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Status: Active, not recruiting Condition: Prostate Cancer

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride
Status: Completed Condition: Benign Prostate Hyperplasia

Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
Status: Active, not recruiting Condition: Prostatic Neoplasms; Low Grade Prostate Cancer

Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer
Status: Completed Condition: Prostate Cancer

Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Status: Active, not recruiting Condition: Benign Prostate Tissue

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Status: Completed Condition: Healthy Males

Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Status: Completed Condition: Prostate Cancer

Dutasteride in Treating Patients With Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)
Status: Active, not recruiting Condition: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Finasteride, Dutasteride and Insulin Action
Status: Recruiting Condition: Healthy Volunteers

Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
Status: Completed Condition: Contraception; Hypogonadism

PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue
Status: Completed Condition: Healthy

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
Status: Completed Condition: Neoplasms, Prostate

Metabolic Effects of Steroids in Obese Men
Status: Active, not recruiting Condition: Obesity; Insulin Resistance

Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
Status: Terminated Condition: Benign Prostatic Hyperplasia

Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
Status: Completed Condition: Prostate Cancer

Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

For Cause Prostate Biopsy in REDUCE Population Trial
Status: Completed Condition: Early Detection of Cancer

A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Status: Enrolling by invitation Condition: Benign Prostatic Hyperplasia

Drug Use Investigation for AVOLVE(BPH)
Status: Completed Condition: Prostatic Hyperplasia

Economic Analyses of the REDUCE Trial
Status: Completed Condition: Neoplasms, Prostate; Benign Prostatic Hyperplasia; Cancer

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Status: Completed Condition: Neoplasms, Prostate

A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Status: Completed Condition: Benign Prostatic Hyperplasia

Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
Status: Active, not recruiting Condition: Cancer; Prostate Neoplasms

Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Status: Completed Condition: Prostatic Hyperplasia

Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Status: Completed Condition: Benign Prostatic Hyperplasia; Prostate Cancer

Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Status: Completed Condition: Benign Prostatic Hyperplasia

Testosterone and Its Metabolites in GID
Status: Completed Condition: Transsexualism

Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker
Status: Completed Condition: Urinary Retention; Benign Prostatic Hyperplasia

Prospective Sexual Function Study for BPH Subjects
Status: Recruiting Condition: Prostatic Hyperplasia

Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Status: Completed Condition: Prostate Cancer

An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
Status: Active, not recruiting Condition: Benign Prostatic Hyperplasia

The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
Status: Not yet recruiting Condition: Prostate Cancer

A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
Status: Completed Condition: Benign Prostatic Hyperplasia

JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Status: Terminated Condition: Benign Prostatic Hyperplasia; Chronic Prostatitis

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men
Status: Completed Condition: Aging

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
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
Roxane
DUTASTERIDE
dutasteride
CAPSULE;ORAL202204-001Nov 23, 2015RXNo<disabled><disabled>
Apotex Inc
DUTASTERIDE
dutasteride
CAPSULE;ORAL204292-001Nov 24, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: dutasteride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,565,467<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,846,976<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,998,427<disabled>
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International Patent Family for Ingredient: dutasteride

Country Document Number Publication Date
South Korea100364953Apr 08, 2003
Russian Federation2144037Jan 10, 2000
European Patent Office0783001Nov 17, 1999
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
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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