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Oxybutynin - Generic Drug Details

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Oxybutynin is the generic ingredient in eight branded drugs marketed by Allergan Sales Llc, Barr Labs Div Teva, Mylan, Osmotica Pharm Us, 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-seven NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-nine patent family members in twenty-two countries.

There are sixteen drug master file entries for oxybutynin. Two suppliers are listed for this compound.

Summary for Generic Name: oxybutynin

Tradenames:8
Patents:15
Applicants:21
NDAs:27
Drug Master File Entries: see list16
Suppliers / Packaging: see list2
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc
GELNIQUE
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYes8,920,392► subscribe ► subscribe
Unique Pharm Labs
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL206121-003May 27, 2016RXNo► subscribe► subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998RXNo5,912,268*PED► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,164,190► subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,834,010► subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 20035,601,839► subscribe
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Non-Orange Book Patents for Generic Ingredient: oxybutynin

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
8,652,491Transdermal compositions for anticholinergic agents► subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► subscribe
7,087,241Compositions 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

Country Document Number Estimated Expiration
Japan4864695► subscribe
Japan2007508261► subscribe
Cyprus1111498► 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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