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Last Updated: November 29, 2022

Oxybutynin chloride - Generic Drug Details


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

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by 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, Novast Labs, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in thirty-eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin chloride has twenty-one patent family members in thirteen countries.

There are nine drug master file entries for oxybutynin chloride. Forty-one suppliers are listed for this compound.

Drug Prices for oxybutynin chloride

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Drug Sales Revenue Trends for oxybutynin chloride

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Recent Clinical Trials for oxybutynin chloride

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

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Pharmacology for oxybutynin chloride
Paragraph IV (Patent) Challenges for OXYBUTYNIN CHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GELNIQUE Gel oxybutynin chloride 10% 022204 1 2014-06-19

US Patents and Regulatory Information for oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abhai Llc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 209335-001 Dec 22, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 207138-002 Feb 29, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ajanta Pharma Ltd OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 211655-002 Feb 28, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emcure Pharms Ltd OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 211682-001 May 10, 2019 BX RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tulex Pharms Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 210125-001 Sep 6, 2018 AB RX No 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 chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 See Plans and Pricing See Plans and Pricing
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 See Plans and Pricing See Plans and Pricing
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 See Plans and Pricing See Plans and Pricing
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 See Plans and Pricing See Plans and Pricing
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxybutynin chloride

Country Patent Number Title Estimated Expiration
Japan 2012526124 See Plans and Pricing
Australia 2010246103 A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions See Plans and Pricing
Mexico 367923 UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.) See Plans and Pricing
Mexico 338166 UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.) See Plans and Pricing
Japan 5485377 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Dow
Harvard Business School
Medtronic
Moodys

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.