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Mallinckrodt
Express Scripts
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Johnson and Johnson
McKesson

Last Updated: July 10, 2020

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OXYTROL Drug 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. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty countries.

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.

US ANDA Litigation and Generic Entry Outlook for Oxytrol

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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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.N/A
Christopher Patrick SmithPhase 3
Watson PharmaceuticalsPhase 4

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Pharmacology for OXYTROL
Paragraph IV (Patent) Challenges for OXYTROL
Tradename Dosage Ingredient NDA Submissiondate
OXYTROL FILM, EXTENDED RELEASE;TRANSDERMAL oxybutynin 021351 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   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.