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Oxybutynin chloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for oxybutynin chloride?

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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: oxybutynin chloride

Tradenames:4
Patents:6
Applicants:20
NDAs:23
Drug Master File Entries: see list16
Suppliers / Packagers: see list47
Bulk Api Vendors: see list49
Clinical Trials: see list222
Patent Applications: see list1,304
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxybutynin chloride at DailyMed

Pharmacology for Ingredient: oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc
GELNIQUE
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes8,241,662► Subscribe ► Subscribe
Usl Pharma
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET;ORAL074625-001Jul 31, 1996RXNoNo► Subscribe► Subscribe
Unique Pharm Labs
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL206121-001May 27, 2016RXNoNo► Subscribe► Subscribe
Janssen Pharms
DITROPAN
oxybutynin chloride
TABLET;ORAL017577-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
Usl Pharma
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET;ORAL070746-001Mar 10, 1988DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 19985,840,754*PED► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 19994,783,337*PED► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 19984,612,008*PED► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 19984,519,801*PED► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 19986,919,092*PED► Subscribe
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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► Subscribe
6,743,441 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,081,252Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,081,249Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,081,250Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
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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
Japan2012526124► Subscribe
Australia2010200418► Subscribe
Australia2010246103► Subscribe
Japan2015131826► Subscribe
Russian Federation2005116678► Subscribe
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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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