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 are sixteen drug master file entries 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: | 89 |
Clinical Trials: | 7 |
Patent Applications: | 3,923 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>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/000532 Symptomatic 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 |
---|---|---|---|
Cyprus | 1111498 | ⤷ Sign Up | |
Mexico | PA05004110 | COMPOSICIONES Y METODOS PARA TERAPIA DE OXIBUTININA TRANSDERMICA. (COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY.) | ⤷ Sign Up |
South Korea | 100275593 | ⤷ Sign Up | |
Argentina | 001721 | Triacetina como un mejorador de la pentración parala transdermal de una droga básica | ⤷ Sign Up |
Norway | 339626 | ⤷ Sign Up | |
Australia | 2001253782 | ⤷ Sign Up | |
Hong Kong | 1013803 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | |
0871420 | 05C0008 | France | ⤷ Sign Up | PRODUCT NAME: OXYBUTININ; REGISTRATION NO/DATE: EU/1/03/270/001 20040615 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |