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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 fifty-nine 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

Drug Master File Entries: see list16
Suppliers: see list5
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxybutynin chloride

Clinical Trials for: oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
oxybutynin chloride
TABLET;ORAL072485-001Apr 19, 1989DISCNNo<disabled><disabled>
oxybutynin chloride
SYRUP;ORAL075039-001Jan 29, 1999DISCNNo<disabled><disabled>
Mylan Pharms Inc
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076644-002May 10, 2007RXNo<disabled><disabled>
Osmotica Pharm
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-002Feb 4, 2009RXNo<disabled><disabled>
oxybutynin chloride
SYRUP;ORAL074868-001Feb 12, 1997RXYes<disabled><disabled>
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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Publication Date
Australia2001253782Jun 29, 2006
Canada2406064Nov 01, 2001
European Patent Office2606865Jun 26, 2013
European Patent Office2612629Jul 10, 2013
New Zealand539562Nov 28, 2008
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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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