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Last Updated: November 24, 2020

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Oxybutynin - Generic Drug Details

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What are the generic drug sources for oxybutynin and what is the scope of patent protection?

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, Par Pharm Inc, Ortho Mcneil Janssen, Anda Repository, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma Inc, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-nine NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has one hundred and twenty patent family members in twenty-three countries.

There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.

Drug Prices for oxybutynin

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Drug Sales Revenue Trends for oxybutynin

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Recent Clinical Trials for oxybutynin

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SponsorPhase
Alliance for Clinical Trials in OncologyPhase 2
National Cancer Institute (NCI)Phase 2
ApnimedPhase 2

See all oxybutynin clinical trials

Pharmacology for oxybutynin
Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename Dosage Ingredient NDA Submissiondate
OXYTROL FILM, EXTENDED RELEASE;TRANSDERMAL oxybutynin 021351 2008-08-19

US Patents and Regulatory Information for oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 072296-001 Dec 8, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Unique Pharm Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121-001 May 27, 2016 AB RX No No   Start Trial   Start Trial   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
Vintage Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 075079-001 Oct 31, 1997 AB RX No Yes   Start Trial   Start Trial   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 oxybutynin

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 FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013   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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