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Last Updated: April 22, 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 patent protection?

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. Thirty-nine 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

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

SponsorPhase
Alliance for Clinical Trials in OncologyPhase 2
National Cancer Institute (NCI)Phase 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
Zydus Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 202332-002 Jun 26, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076745-002 May 9, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avet Lifesciences OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 211682-001 May 10, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 074625-001 Jul 31, 1996 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharm Assoc OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 074997-001 Oct 15, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 DISCN Yes 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 020897-003 Jun 22, 1999 ⤷  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 020897-002 Dec 16, 1998 ⤷  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
Abbvie GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 ⤷  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 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.) ⤷  Try a Trial
China 102421411 A method for treating overactive bladders and a 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
Australia 2010246103 A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions ⤷  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
Spain 2721513 ⤷  Try a Trial
Mexico 2019011031 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
>Country >Patent Number >Title >Estimated Expiration

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