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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 Us, 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-eight 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
Drug Prices:see low prices

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
Impax Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076745-001Nov 9, 2006RXNo
Vintage Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET;ORAL075079-001Oct 31, 1997RXYes
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999RXYes6,262,115*PEDNov 22, 2015
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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;ORAL020897-003Jun 22, 19996,262,115*PED<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 19985,840,754*PED<disabled>
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 19995,912,268*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
7,087,241Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy<disabled in preview>
6,124,355 Oxybutynin therapy<disabled in preview>
6,743,441 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: oxybutynin chloride

Country Document Number Estimated Expiration
Japan2013082720<disabled in preview>
Canada2504021<disabled in preview>
New Zealand307116<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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