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Details for Generic Name: finasteride

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Finasteride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Accord Hlthcare Inc, Actavis Totowa, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Sun Pharma Global, Teva, Zydus Pharms Usa Inc, and Merck, and is included in twenty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has six patent family members in five countries.

There are thirteen drug master file entries for finasteride. Three suppliers are listed for this compound.

Summary for Generic Name: finasteride

Tradenames:3
Patents:1
Applicants:17
NDAs:22
Drug Master File Entries: see list13
Suppliers / Packaging: see list8
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: finasteride

Clinical Trials for: finasteride

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

Finasteride for Chronic Central Serous Chorioretinopathy
Status: Terminated Condition: Retinal Disease

A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
Status: Completed Condition: Enlarged Prostate

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Status: Completed Condition: Retinal Disease

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Status: Completed Condition: Retinal Disease

Finasteride Treatment of Severe Nodulocystic Acne
Status: Recruiting Condition: NODULOCYSTIC ACNE

The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy
Status: Terminated Condition: Hematuria; Hematospermia

On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Status: Withdrawn Condition: Benign Prostatic Hyperplasia

Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate; Stage II Prostate Cancer

Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021)
Status: Recruiting Condition: Male Breast Cancer

Kinetics of the Finasteride Prostate Induced Apoptosis
Status: Active, not recruiting Condition: Benign Prostatic Hyperplasia

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

Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Status: Not yet recruiting Condition: Spinal Cord Injury; Spinal Cord Injuries; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male

PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
Status: Completed Condition: Benign Prostatic Hyperplasia (BPH)

A Phase 2 Study of Bicalutamide Plus Finasteride in Men With MRI Detectable Prostate Nodules Undergoing Active Surveillance
Status: Not yet recruiting Condition: Detectable Prostate Nodules

The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Status: Not yet recruiting Condition: Female Androgenetic Alopecia

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
Status: Terminated Condition: Benign Prostatic Hyperplasia

Topical Finasteride in the Treatment of Idiopathic Hirsutism
Status: Completed Condition: Idiopathic Hirsutism

Finasteride 5 mg Tablets, Non-fasting
Status: Completed Condition: Healthy

Finasteride 5 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Status: Recruiting Condition: Non-small Cell Lung Cancer

Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia
Status: Completed Condition: Androgenetic Alopecia

Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
Status: Completed Condition: Androgenetic Alopecia

Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
Status: Active, not recruiting Condition: Benign Prostate Hyperplasia

Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg
Status: Completed Condition: Healthy

Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg
Status: Completed Condition: Healthy

Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

5-Alpha Reductase and Anabolic Effects of Testosterone
Status: Completed Condition: Male Hypogonadism; Muscle Atrophy; Sarcopenia; Benign Prostate Hypertrophy

Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
Status: Completed Condition: Prostatic Hyperplasia

High Risk Prostate Cancer Prevention Study
Status: Completed Condition: Prostate Cancer

Oral T7 Oral Testosterone in Man
Status: Completed Condition: Healthy Males; Male Contraceptive

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

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Status: Completed Condition: Benign Prostatic Hyperplasia; Enlarged Prostate

Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
Status: Completed Condition: Androgenetic Alopecia

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

ORAL T-6: Oral Androgens in Man-6
Status: Completed Condition: Contraception; Hypogonadism

Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
Status: Completed Condition: Benign Prostatic Hyperplasia (BPH); Enlarged Prostate

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

Minimally Invasive Surgical Therapy for BPH
Status: Terminated Condition: Benign Prostatic Hyperplasia

Medical Therapy of Prostatic Symptoms (MTOPS)
Status: Completed Condition: Prostatic Hyperplasia; Prostatic Hypertrophy, Benign

A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
Status: Active, not recruiting Condition: Androgenetic Alopecia

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

UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
Status: Recruiting Condition: Cystocele

Hormone Therapy in Treating Patients With Prostate Cancer
Status: Completed Condition: Prostate Cancer; Sexual Dysfunction and Infertility

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Status: Completed Condition: Prostatic Hyperplasia

Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy
Status: Completed Condition: Benign Prostatic Hyperplasia

Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
Status: Completed Condition: Prostatic Hyperplasia

Pharmacogenomic Study of Androgenetic Alopecia
Status: Not yet recruiting Condition: Androgenetic Alopecia

Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Status: Completed Condition: Prostatic Hyperplasia

A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
Status: Completed Condition: Benign Prostatic Hyperplasia

Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
Status: Completed Condition: Prostatic Hyperplasia

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
Status: Completed Condition: Prostatic Hyperplasia

S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
Status: Terminated Condition: Prostate Cancer

Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
Status: Completed Condition: Androgenetic Alopecia

Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
Status: Completed Condition: Androgenic Alopecia

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan
Status: Completed Condition: Prostatic Hyperplasia

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

Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
Status: Completed 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
Mylan Pharms Inc
FINASTERIDE
finasteride
TABLET;ORAL078161-001Nov 5, 2013RXNo<disabled><disabled>
Teva
FINASTERIDE
finasteride
TABLET;ORAL076511-001Dec 15, 2006RXNo<disabled><disabled>
Actavis Totowa
FINASTERIDE
finasteride
TABLET;ORAL077914-001Mar 28, 2007RXNo<disabled><disabled>
Gedeon Richter Usa
FINASTERIDE
finasteride
TABLET;ORAL077251-001Dec 22, 2006RXNo<disabled><disabled>
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992RXYes5,942,519<disabled><disabled>
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International Patent Family for Ingredient: finasteride

Country Document Number Publication Date
European Patent Office1032400Sep 06, 2000
Australia1279099May 17, 1999
European Patent Office1032400Apr 12, 2006
Canada2308070May 06, 1999
Australia731576Apr 05, 2001
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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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