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Generated: June 23, 2017
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, 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 twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 8 |
| Patents: | 12 |
| Applicants: | 21 |
| NDAs: | 27 |
| Drug Master File Entries: see list | 16 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 51 |
| Clinical Trials: see list | 71 |
| Patent Applications: see list | 4,954 |
| Therapeutic Class: | Genitourinary Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | oxybutynin at DailyMed |
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Quantum Pharmics | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 072296-001 | Dec 8, 1988 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-001 | Dec 16, 1998 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Ortho Mcneil Janssen | DITROPAN | oxybutynin chloride | SYRUP;ORAL | 018211-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Vintage Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 076682-001 | Dec 28, 2004 | AA | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Pharms | DITROPAN | oxybutynin chloride | TABLET;ORAL | 017577-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan Sales Llc | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 5,834,010 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | 5,601,839 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 5,164,190 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 5,601,839 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | 5,834,010 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,214,381 | Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels | ► Subscribe | |||||||||||||||||||||||||||
| 7,087,241 | Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy | ► Subscribe | |||||||||||||||||||||||||||
| 7,404,965 | Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels | ► Subscribe | |||||||||||||||||||||||||||
| 7,387,788 | Pharmaceutical compositions of nicotine and methods of use thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,652,491 | Transdermal compositions for anticholinergic agents | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Africa | 200602046 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20110043725 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 546106 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20130026510 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1280486 | ► 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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