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Oxybutynin chloride - Generic Drug Details

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Oxybutynin chloride is the generic ingredient in four branded drugs marketed by Mylan, Osmotica Pharm, Allergan Sales Llc, Amneal Pharms, Ortho Mcneil Janssen, Silarx, Unique Pharm Labs, Usl Pharma, Pharm Assoc, Accord Hlthcare, Mikart, Mylan Pharms Inc, Impax Pharms, Teva Pharms Usa, Wockhardt, Janssen Pharms, Vintage Pharms, Watson Labs, Quantum Pharmics, and Apotex Inc, and is included in twenty-three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-six patent family members in twenty-six countries.

There are sixteen drug master file entries for oxybutynin chloride. Forty-four suppliers are listed for this compound.

Summary for Generic Name: oxybutynin chloride

Tradenames:4
Patents:9
Applicants:20
NDAs:23
Drug Master File Entries: see list16
Suppliers / Packaging: see list44
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
Accord Hlthcare
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL207138-002Feb 29, 2016RXNo<disabled><disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998RXNo5,674,895*PED<disabled> <disabled>
Osmotica Pharm
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-003Feb 4, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: oxybutynin chloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 19984,783,337*PED<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 19984,612,008*PED<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 19995,082,668*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: oxybutynin chloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,081,249Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy<disabled in preview>
6,919,092 Method for the management of incontinence<disabled in preview>
7,087,241Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy<disabled in preview>
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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Estimated Expiration
South Korea20120038026<disabled in preview>
China101843601<disabled in preview>
Canada2406064<disabled in preview>
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