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Last Updated: March 28, 2024

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.

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

See all OXYTROL clinical trials

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 ⤷  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

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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 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.