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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 patent family members in nineteen 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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999RXYes6,262,115*PED<disabled>Y<disabled>
Actavis Labs Ut Inc
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYes7,179,483<disabled><disabled>
Osmotica Pharm
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-001Feb 4, 2009RXNo<disabled><disabled>
Ortho Mcneil Janssen
oxybutynin chloride
SYRUP;ORAL018211-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076702-001Nov 9, 2006RXNo<disabled><disabled>
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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Publication Date
South Africa200503316Aug 30, 2006
Germany10772664Sep 27, 2012
Denmark1565136Apr 20, 2015
Australia2010246103Nov 24, 2011
Spain2532495Mar 27, 2015
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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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