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Generated: August 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, Zydus Pharms Usa Inc, 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-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.| Tradenames: | 8 |
| Patents: | 11 |
| Applicants: | 22 |
| NDAs: | 28 |
| Drug Master File Entries: see list | 16 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 51 |
| Clinical Trials: see list | 72 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 071655-001 | Nov 14, 1988 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Impax Pharms | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 076745-001 | Nov 9, 2006 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Janssen Pharms | DITROPAN XL | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 020897-003 | Jun 22, 1999 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Unique Pharm Labs | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 206121-001 | May 27, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Accord Hlthcare | OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 207138-003 | Feb 29, 2016 | AB | RX | No | No | ► Subscribe | ► 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,470,433 | Formulations for transdermal or transmucosal application | ► Subscribe | |||||||||||||||||||||||||||
| 7,335,379 | Transdermal pharmaceutical formulation for minimizing skin residues | ► Subscribe | |||||||||||||||||||||||||||
| 7,387,788 | Pharmaceutical compositions of nicotine and methods of use thereof | ► 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 | |||||||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 586108 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1997357 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1670433 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60143360 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2283665 | ► 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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