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Serving leading biopharmaceutical companies globally:

Moodys
Deloitte
Cipla
Covington
McKinsey
Cerilliant
Chubb
Fuji
Farmers Insurance
Merck

Generated: December 14, 2017

DrugPatentWatch Database Preview

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 Barr Labs Div Teva, Allergan Sales Llc, Ortho Mcneil Janssen, Apotex Inc, Mikart, Pharm Assoc, Silarx, Vintage Pharms, Wockhardt, Janssen Pharms, Accord Hlthcare, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms Usa Inc, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Upsher-smith Labs, Usl Pharma, and Watson Labs, and is included in twenty-nine 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.

Pharmacology for oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Allergan Sales LlcOXYTROL FOR WOMENoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Allergan Sales LlcGELNIQUE 3%oxybutyninGEL, METERED;TRANSDERMAL202513-001Dec 7, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Allergan Sales LlcGELNIQUEoxybutynin chlorideGEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Accord HlthcareOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL207138-003Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL202332-002Jun 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcOXYTROL FOR WOMENoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Accord HlthcareOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL207138-002Feb 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcGELNIQUEoxybutynin chlorideGEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL204010-001Nov 23, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Osmotica Pharm UsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL078503-001Feb 4, 2009ABRXNoNo► Subscribe► 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 LlcOXYTROL FOR WOMENoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013► Subscribe► Subscribe
Allergan Sales LlcOXYTROLoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales LlcOXYTROL FOR WOMENoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL202211-001Jan 25, 2013► Subscribe► Subscribe
Allergan Sales LlcOXYTROLoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales LlcOXYTROLoxybutyninFILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► 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
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
7,470,433Formulations for transdermal or transmucosal application► Subscribe
7,387,788Pharmaceutical compositions of nicotine and methods of use thereof► Subscribe
7,087,241Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► 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
Brazil0110381► Subscribe
Australia2004220498► Subscribe
European Patent Office1648406► Subscribe
Germany60127134► Subscribe
Japan2007524589► Subscribe
Spain2283665► Subscribe
Russian Federation2005116678► Subscribe
New Zealand541854► Subscribe
Canada2515426► Subscribe
Canada2718277► 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:

UBS
QuintilesIMS
Farmers Insurance
Cerilliant
Fish and Richardson
Dow
McKesson
Daiichi Sankyo
Chubb
Citi

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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