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Details for Generic Name: oxybutynin chloride

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Oxybutynin chloride is the generic ingredient in four branded drugs marketed by Actavis Labs Ut Inc, Ortho Mcneil Janssen, Apotex Inc, Mikart, Pharm Assoc, Silarx, Vintage Pharms, Wockhardt, Janssen Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm, Quantum Pharmics, Teva Pharms Usa, Usl Pharma, and Watson Labs, and is included in twenty NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty patent family members in nineteen countries.

There are sixteen drug master file entries for oxybutynin chloride. Five suppliers are listed for this compound.

Summary for Generic Name: oxybutynin chloride

Tradenames:4
Patents:8
Applicants:17
NDAs:20
Drug Master File Entries: see list16
Suppliers / Packaging: see list11
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxybutynin chloride

Clinical Trials for: oxybutynin chloride

Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
Status: Not yet recruiting Condition: Hyperhidrosis

An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Status: Completed Condition: Urinary Bladder, Overactive

OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER
Status: Recruiting Condition: Overactive Bladder

Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
Status: Completed Condition: Healthy Volunteers

The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
Status: Completed Condition: Menopause; Hot Flashes

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
Status: Completed Condition: Hyperhidrosis

Treatment of Hyperhidrosis With Oxybutynin
Status: Completed Condition: Hyperhidrosis

Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
Status: Suspended Condition: Overactive Detrusor; Neurogenic Bladder

Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
Status: Completed Condition: Healthy

Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
Status: Completed Condition: Healthy

Fed Study of Oxybutynin Chloride Extended-Release Tablets 10 mg and Ditropan XL® Tablets 10 mg
Status: Completed Condition: Healthy

Food Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg
Status: Completed Condition: Healthy

Fasting Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg
Status: Completed Condition: Healthy

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Status: Completed Condition: Urge Urinary Incontinence; Urinary Frequency

Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg
Status: Completed Condition: Healthy

Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children
Status: Enrolling by invitation Condition: Overactive Bladder

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Status: Completed Condition: Post-nasal Drip; Seasonal Allergic Rhinitis; Rhinorrhea

Use of Oxybutynin to Treat Axillary Hyperhidrosis
Status: Completed Condition: Axillary Hyperhidrosis; Osmidrosis

A Study to Compare Oxybutynin to a Placebo in Women and the Effect on Plantar Hyperhidrosis
Status: Completed Condition: Hyperhidrosis

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment
Status: Not yet recruiting Condition: Overactive Bladder; Mild Cognitive Impairment

An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.
Status: Completed Condition: Urination Disorders

Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Status: Completed Condition: Detrusor Hyperreflexia

A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence
Status: Completed Condition: Urinary Incontinence

Effects of Oxybutynin Topical Gel on Gastric Emptying
Status: Completed Condition: Healthy

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Status: Completed Condition: Overactive Bladder

Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
Status: Not yet recruiting Condition: Overactive Bladder

Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Status: Terminated Condition: Detrusor Function, Overactive

Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Status: Completed Condition: Healthy Volunteers

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Status: Completed Condition: Overactive Bladder

Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
Status: Recruiting Condition: Urinary Urge Incontinence

Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder
Status: Completed Condition: Urinary Incontinence

A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Status: Completed Condition: Detrusor Hyperreflexia

A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Status: Completed Condition: Urinary Incontinence, Urge

Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population
Status: Not yet recruiting Condition: Disorder of Urinary Stent

A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Status: Completed Condition: Overactive Bladder

A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Status: Completed Condition: Spinal Cord Injury

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Status: Completed Condition: Overactive Bladder

A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.
Status: Completed Condition: Urge Incontinence

Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder
Status: Completed Condition: Overactive Bladder; Urinary Incontinence; Quality of Life

Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Status: Completed Condition: Neurogenic Bladder

Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
Status: Completed Condition: Urinary Incontinence

Oxybutynin and Omega-3 for OAB (Overactive Bladder)
Status: Terminated Condition: Overactive Bladder

Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis
Status: Completed Condition: Hyperhidrosis

Enhancing Conservative Treatment for Urge Incontinence
Status: Completed Condition: Urinary Incontinence

A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability
Status: Completed Condition: Cognition

A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Status: Completed Condition: Sialorrhoea

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Status: Recruiting Condition: Urinary Bladder, Neurogenic

Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence.
Status: Completed Condition: Urinary Incontinence Mixed (Stress and Urge)

Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome
Status: Recruiting Condition: Overactive Bladder

Behavioral Treatment of Overactive Bladder in Men
Status: Completed Condition: Overactive Bladder

Effects Of Detrol LA On Memory And Cognition In Elderly Population
Status: Completed Condition: Memory; Cognition

Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Status: Completed Condition: Spinal Cord Injury; Neurogenic Detrusor Overactivity

Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Status: Completed Condition: Neurogenic Bladder; Spinal Cord Diseases; Multiple Sclerosis

Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
Status: Recruiting Condition: Anterior Cruciate Ligament Rupture

An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults
Status: Terminated Condition: Polypharmacy; Incontinence; Insomnia; Anxiety

Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
Status: Completed Condition: Parkinson's Disease; Overactive Bladder

A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
Status: Recruiting Condition: Overactive Bladder; Urinary Bladder Overactive; Urinary Bladder Diseases; Urologic Diseases

Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Status: Active, not recruiting Condition: Myelomeningocele; Bladder, Neurogenic

Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence : Hypnotherapy Or Pharmacotherapy
Status: Recruiting Condition: Urinary Incontinence, Urge

Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
Status: Completed Condition: Overactive Bladder (OAB)

InSite for Over Active Bladder
Status: Active, not recruiting Condition: Urinary Incontinence, Urgency-frequency,; Overactive Bladder

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
Osmotica Pharm
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-002Feb 4, 2009RXNo<disabled><disabled>
Impax Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076745-001Nov 9, 2006RXNo<disabled><disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999RXYes5,840,754*PED<disabled>Y<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998RXNo5,840,754*PED<disabled>Y<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998RXNo5,912,268*PED<disabled>Y<disabled>
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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Publication Date
Norway20052625May 31, 2005
Canada2406064Nov 01, 2001
Brazil0110381Dec 30, 2003
European Patent Office1565136Feb 25, 2015
Canada2821174Nov 11, 2010
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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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