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.
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: | 3,925 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for OXYTROL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | OXYTROL FOR WOMEN | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 202211-001 | Jan 25, 2013 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351-002 | Feb 26, 2003 | ⤷ Try a Trial | ⤷ Try a 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/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 |
---|---|---|---|
China | 100374161 | ⤷ Try a Trial | |
Australia | 5446796 | ⤷ Try a Trial | |
Australia | 2012216593 | Compositions and methods for transdermal oxybutynin therapy | ⤷ Try a Trial |
Portugal | 871420 | ⤷ Try a Trial | |
European Patent Office | 1280486 | REDUCTION D'EPISODES INDESIRABLES ASSOCIES A UNE THERAPIE PAR L'OXYBUTYNINE (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY) | ⤷ Try a Trial |
Canada | 2217888 | UTILISATION DE LA TRIACETINE COMME STIMULATION DE PENETRATION TRANSDERMIQUE (TRIACETIN AS A TRANSDERMAL PENETRATION ENHANCER) | ⤷ Try a Trial |
Portugal | 99751 | PROCESSO DE PREPARACAO DE UM DISPOSITIVO DE LIBERTACAO TRANSDERMICA DE FARMACO SUB-SATURADO EXIBINDO INCREMENTO DO FLUXO DE FARMACO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OXYTROL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0871420 | 05C0008 | France | ⤷ Try a Trial | PRODUCT NAME: OXYBUTININ; REGISTRATION NO/DATE: EU/1/03/270/001 20040615 |
0871420 | CA 2005 00010 | Denmark | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |