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Generated: October 19, 2017

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Oxybutynin - Generic Drug Details

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What are the generic drug sources for oxybutynin and what is the scope of oxybutynin freedom to operate?

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, Upsher-smith Labs, Zydus Pharms Usa Inc, Pharm Assoc, Accord Hlthcare, Mikart, Mylan Pharms Inc, Impax Pharms, Usl Pharma, Teva Pharms Usa, Wockhardt, Janssen Pharms, Vintage Pharms, Watson Labs, Quantum Pharmics, and Apotex Inc, and is included in twenty-eight NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has one hundred and fourteen 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

US Patents:11
Tradenames:8
Applicants:23
NDAs:28
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Bulk Api Vendors: see list51
Clinical Trials: see list73
Patent Applications: see list5,102
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxybutynin at DailyMed

Pharmacology for Ingredient: oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osmotica Pharm Us
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-002Feb 4, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Silarx
OXYBUTYNIN CHLORIDE
oxybutynin chloride
SYRUP;ORAL074520-001Mar 29, 1996AARXNoNo► Subscribe► Subscribe► Subscribe
Mylan
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076702-001Nov 9, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan Sales Llc
GELNIQUE
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013OTCYesYes► Subscribe► SubscribeY ► Subscribe
Impax Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076745-001Nov 9, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan Sales Llc
GELNIQUE 3%
oxybutynin
GEL, METERED;TRANSDERMAL202513-001Dec 7, 2011DISCNYesNo► Subscribe► Subscribe ► Subscribe
Pharm Assoc
OXYBUTYNIN CHLORIDE
oxybutynin chloride
SYRUP;ORAL075137-001Dec 18, 1998AARXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
OXYBUTYNIN CHLORIDE
oxybutynin chloride
SYRUP;ORAL074997-001Oct 15, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998ABRXYesNo► Subscribe► 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, 2003► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL FOR WOMEN
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013► Subscribe► 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
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
7,087,241Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,470,433Formulations for transdermal or transmucosal application► Subscribe
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
7,387,788Pharmaceutical compositions of nicotine and methods of use thereof► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► 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
European Patent Office1307232► Subscribe
China105853396► Subscribe
China101305994► Subscribe
Canada2718277► Subscribe
Germany60127277► Subscribe
Cyprus1111498► Subscribe
World Intellectual Property Organization (WIPO)2004080413► Subscribe
Australia2003287377► Subscribe
Japan2017008085► Subscribe
Australia2012216593► 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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
Cerilliant
Medtronic
QuintilesIMS
Cantor Fitzgerald
US Department of Justice
Colorcon
Chubb
Teva

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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