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Last Updated: March 28, 2024

Oxybutynin chloride - Generic Drug Details


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

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by 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, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Eywa, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, 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-two patent family members in thirteen countries.

There are nine drug master file entries for oxybutynin chloride. Forty 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
Alliance for Clinical Trials in OncologyPhase 2
National Cancer Institute (NCI)Phase 2
National Institute on Disability, Independent Living, and Rehabilitation ResearchPhase 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
Mylan OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076702-001 Nov 9, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 210717-003 Dec 17, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novitium Pharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 209823-001 Oct 23, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076745-003 May 9, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 211655-003 Feb 28, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tulex Pharms Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 210125-001 Sep 6, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 204010-003 Nov 23, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 ⤷  Try a Trial ⤷  Try a Trial
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for oxybutynin chloride

Country Patent Number Title Estimated Expiration
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.) ⤷  Try a Trial
Russian Federation 2011144397 СПОСОБ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ МОЧЕВОГО ПУЗЫРЯ И УСТРОЙСТВО ДЛЯ ХРАНЕНИЯ И ПРИМЕНЕНИЯ КОМПОЗИЦИИ ОКСИБУТИНИНА МЕСТНОГО ДЕЙСТВИЯ ⤷  Try a Trial
Japan 2014144957 METHOD FOR TREATING OVERACTIVE BLADDERS AND DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS ⤷  Try a Trial
South Korea 20120030078 A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS ⤷  Try a Trial
Japan 5485377 ⤷  Try a Trial
Brazil PI1015542 um método para tratar bexigas hiperativas e um dispositivo para armazenamento e administração de composições tópicas de oxibutinina ⤷  Try a Trial
Canada 2760867 PROCEDE DE TRAITEMENT DE VESSIES HYPERACTIVES ET DISPOSITIF DE STOCKAGE ET D'ADMINISTRATION DE COMPOSITIONS TOPIQUES D'OXYBUTYNINE (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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