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Last Updated: November 22, 2024

OXYBUTYNIN - Generic Drug Details


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What are the generic 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, Abbvie, Chartwell Rx, Ortho Mcneil Janssen, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Norvium Bioscience, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Hibrow Hlthcare, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Trupharma, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in forty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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
Reinier de Graaf GroepPhase 3
Il-Yang Pharm. Co., Ltd.Phase 2
Seoul National University HospitalPhase 2

See all OXYBUTYNIN clinical trials

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
Lannett Co Inc OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 074520-001 Mar 29, 1996 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 202332-001 Jun 26, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Osmotica Pharm Us OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503-002 Feb 4, 2009 AB RX No No ⤷  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 OXYBUTYNIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Abbvie OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Abbvie OXYTROL FOR WOMEN oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 202211-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
>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

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