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Generated: October 20, 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 Mylan, Osmotica Pharm Us, Allergan Sales Llc, 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-four 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-seven patent family members in twenty countries.

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

Summary for Generic Name: oxybutynin chloride

US Patents:5
Tradenames:4
Applicants:22
NDAs:24
Drug Master File Entries: see list16
Suppliers / Packagers: see list52
Bulk Api Vendors: see list49
Clinical Trials: see list517
Patent Applications: see list2,099
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unique Pharm Labs
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL206121-001May 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
OXYBUTYNIN CHLORIDE
oxybutynin chloride
SYRUP;ORAL074997-001Oct 15, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL204010-003Nov 23, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan Sales Llc
GELNIQUE
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Amneal Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL204010-001Nov 23, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms
OXYBUTYNIN CHLORIDE
oxybutynin chloride
SYRUP;ORAL076682-001Dec 28, 2004AARXNoNo► Subscribe► Subscribe► Subscribe
Mylan
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL076702-001Nov 9, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Osmotica Pharm Us
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL078503-003Feb 4, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan Sales Llc
GELNIQUE
oxybutynin chloride
GEL;TRANSDERMAL022204-001Jan 27, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Upsher-smith Labs
OXYBUTYNIN CHLORIDE
oxybutynin chloride
TABLET;ORAL074625-001Jul 31, 1996ABRXNoNo► 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 Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► 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
7,081,252Compositions 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
7,081,250Compositions 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
7,087,241Compositions 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
Canada2821174► Subscribe
Japan5770582► Subscribe
Japan5485377► Subscribe
South Africa201108213► Subscribe
Spain2357699► Subscribe
South Korea20120038026► Subscribe
Japan2014144957► Subscribe
Brazil0110381► Subscribe
Australia2010200418► Subscribe
Mexico342305► 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:

Daiichi Sankyo
Covington
Harvard Business School
Teva
Cipla
US Army
Medtronic
Accenture
QuintilesIMS
Fuji

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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