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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Fish and Richardson
Chubb
Chinese Patent Office
Cerilliant
Farmers Insurance
Covington
AstraZeneca
Baxter

Generated: December 12, 2017

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Oxybutynin chloride - Generic Drug Details

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

Oxybutynin chloride
is the generic ingredient in four branded drugs marketed by 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-five NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin chloride has seventy-eight patent family members in twenty countries.

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

Pharmacology for oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil JanssenDITROPANoxybutynin chlorideSYRUP;ORAL018211-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax PharmsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL076745-003May 9, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL202332-001Jun 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcGELNIQUEoxybutynin chlorideGEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET;ORAL072485-001Apr 19, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Osmotica Pharm UsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL078503-001Feb 4, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharm AssocOXYBUTYNIN CHLORIDEoxybutynin chlorideSYRUP;ORAL075137-001Dec 18, 1998AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL076644-002May 10, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcGELNIQUEoxybutynin chlorideGEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Osmotica Pharm UsOXYBUTYNIN CHLORIDEoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL078503-002Feb 4, 2009ABRXNoNo► Subscribe► Subscribe► 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 PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► 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
6,743,441 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,087,241Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy► Subscribe
7,081,251Compositions 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
7,081,250Compositions 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
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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
Japan6077294► Subscribe
China102327253► Subscribe
Japan2013082720► Subscribe
South Korea20110043725► Subscribe
Japan5485377► Subscribe
Australia2001253782► Subscribe
South Korea20120030078► Subscribe
Japan2006513161► Subscribe
BrazilPI1015542► Subscribe
Denmark1280486► 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:

McKinsey
Medtronic
Baxter
Cantor Fitzgerald
Novartis
McKesson
Cipla
Express Scripts
Daiichi Sankyo
AstraZeneca

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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