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Last Updated: September 25, 2022

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 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.

Drug patent expirations by year for OXYTROL
Drug Prices for OXYTROL

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Drug Sales Revenue Trends for OXYTROL

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Recent Clinical Trials for OXYTROL

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SponsorPhase
Astellas Scientific & Medical Affairs, Inc.
Christopher Patrick SmithPhase 3
BayerPhase 3

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Pharmacology 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 See Plans and Pricing See Plans and Pricing
>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
European Patent Office 1992342 Minimisation d'expérience indésirable associée à la thérapie oxybutynine (Minimizing adverse experience associated with oxybutynin therapy) See Plans and Pricing
Portugal 1280486 See Plans and Pricing
Argentina 001721 Triacetina como un mejorador de la pentración parala transdermal de una droga básica See Plans and Pricing
Austria 205694 See Plans and Pricing
Canada 2406064 REDUCTION D'EPISODES INDESIRABLES ASSOCIES A UNE THERAPIE PAR L'OXYBUTYNINE (MINIMIZING ADVERSE EXPERIENCE ASSOCIATED WITH OXYBUTYNIN THERAPY) See Plans and Pricing
Japan 2012046526 COMPOSITION AND METHOD FOR TRANSDERMAL OXYBUTYNIN THERAPY See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Baxter
Boehringer Ingelheim
Johnson and Johnson
McKesson

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 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.