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Last Updated: September 26, 2022

Oxybutynin - Generic Drug Details


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What are the generic drug sources for oxybutynin and what is the scope of freedom to operate?

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, Strides Pharma, Ortho Mcneil Janssen, Chartwell Rx, 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, Rubicon, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Appco, Beximco Pharms Usa, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in forty-two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has fifty-five patent family members in twenty 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

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

SponsorPhase
Science Valley Research InstitutePhase 2
Samantha Rodrigues Camargo Neves de MouraPhase 2
Northwestern UniversityN/A

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Pharmacology for oxybutynin
Paragraph IV (Patent) Challenges for OXYBUTYNIN
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 oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rubicon OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 214415-002 Oct 27, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unique Pharm Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121-003 May 27, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beximco Pharms Usa OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 213550-001 Jul 14, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 202332-003 Jun 26, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 AB RX Yes No 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 oxybutynin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan GELNIQUE 3% oxybutynin GEL, METERED;TRANSDERMAL 202513-001 Dec 7, 2011 See Plans and Pricing See Plans and Pricing
Allergan OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 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 oxybutynin

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 oxybutynin

Country Patent Number Title Estimated Expiration
Australia 2001282064 See Plans and Pricing
South Africa 200602046 Transdermal pharmaceutical formulation for minimizing skin residues See Plans and Pricing
Hong Kong 1225311 See Plans and Pricing
Japan 5441966 See Plans and Pricing
Japan 2007508261 See Plans and Pricing
Spain 2283425 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Moodys
McKesson
McKinsey
Johnson and Johnson

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