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Last Updated: November 4, 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.

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Summary for OXYTROL
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

Identify potential brand extensions & 505(b)(2) entrants

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 ⤷  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

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