OXYTROL Drug Patent Profile
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When do Oxytrol patents expire, and what generic alternatives are available?
Oxytrol is a drug marketed by Allergan and Abbvie and is included in two NDAs.
The generic ingredient in OXYTROL is oxybutynin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.
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Questions you can ask:
- What is the 5 year forecast for OXYTROL?
- What are the global sales for OXYTROL?
- What is Average Wholesale Price for OXYTROL?
Summary for OXYTROL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,321 |
| Drug Prices: | Drug price information for OXYTROL |
| What excipients (inactive ingredients) are in OXYTROL? | OXYTROL excipients list |
| DailyMed Link: | OXYTROL at DailyMed |
Recent Clinical Trials for OXYTROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Scientific & Medical Affairs, Inc. | |
| Christopher Patrick Smith | Phase 3 |
| Bayer | Phase 3 |
Pharmacology for OXYTROL
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Paragraph IV (Patent) Challenges for OXYTROL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OXYTROL | Transdermal System Extended-release | oxybutynin | 3.9 mg/24 hrs | 021351 | 1 | 2008-08-19 |
US Patents and Regulatory Information for OXYTROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | OTC | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OXYTROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 5,164,190 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 7,081,252 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 7,179,483 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 7,081,251 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 6,743,441 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 5,834,010 | ⤷ Start Trial |
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | 7,081,249 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OXYTROL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Teva B.V. | Kentera (previously Oxybutynin Nicobrand) | oxybutynin | EMEA/H/C/000532Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder. | Authorised | no | no | no | 2004-06-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OXYTROL
See the table below for patents covering OXYTROL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 225166 | ⤷ Start Trial | |
| Australia | 651165 | ⤷ Start Trial | |
| Australia | 9175791 | ⤷ Start Trial | |
| Canada | 2098195 | DISPOSITIF D'ADMINISTRATION, PAR VOIE PERCUTANEE, DE MEDICAMENTS DONT LA CONCENTRATION EST SOUS-SATUREE; CE DISPOSITIF PERMET UN MEILLEUR ECOULEMENT DU MEDICAMENT (SUBSATURATED TRANSDERMAL DRUG DELIVERY DEVICE EXHIBITING ENHANCED DRUG FLUX) | ⤷ Start Trial |
| Germany | 69133123 | ⤷ Start Trial | |
| Denmark | 0562041 | ⤷ Start Trial | |
| European Patent Office | 0562041 | DISPOSITIF D'ACHEMINEMENT TRANSDERMIQUE SOUS-SATURE DE MEDICAMENT PRESENTANT UN MEILLEUR FLUX MEDICAMENTEUX (SUBSATURATED TRANSDERMAL DRUG DELIVERY DEVICE EXHIBITING ENHANCED DRUG FLUX) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OXYTROL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0871420 | CA 2005 00010 | Denmark | ⤷ Start Trial | |
| 0871420 | 05C0008 | France | ⤷ Start Trial | PRODUCT NAME: OXYBUTININ; REGISTRATION NO/DATE: EU/1/03/270/001 20040615 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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