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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 and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-two patent family members in twenty countries.

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

Summary for Generic Name: oxybutynin chloride

Drug Master File Entries: see list16
Suppliers / Packaging: see list11
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxybutynin chloride

Tentative approvals for OXYBUTYNIN CHLORIDE

Applicant Application No. Form Dosage

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

Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Status: Completed Condition: Nocturnal Enuresis

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

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
Actavis Labs Ut Inc
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYes8,920,392<disabled> <disabled>
oxybutynin chloride
SYRUP;ORAL075039-001Jan 29, 1999DISCNNo<disabled><disabled>
Actavis Labs Ut Inc
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYes7,029,694<disabled>Y <disabled>
Usl Pharma
oxybutynin chloride
TABLET;ORAL074625-001Jul 31, 1996RXNo<disabled><disabled>
Janssen Pharms
oxybutynin chloride
TABLET;ORAL017577-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Publication Date
Germany10772664Apr 25, 2013
Canada2760867Sep 24, 2013
Australia2012216593Sep 20, 2012
South Korea20050061588Jun 22, 2005
MexicoPA02010542Oct 14, 2003
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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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