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, 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 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.

Summary for OXYBUTYNIN CHLORIDE

International Patents:	22
US Patents:	3
Tradenames:	4
Applicants:	32
NDAs:	38
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	23
Patent Applications:	2,577
Drug Prices:	Drug price trends for OXYBUTYNIN CHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYBUTYNIN CHLORIDE
What excipients (inactive ingredients) are in OXYBUTYNIN CHLORIDE?	OXYBUTYNIN CHLORIDE excipients list
DailyMed Link:	OXYBUTYNIN CHLORIDE at DailyMed

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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

Sponsor	Phase
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2
National Cancer Institute (NCI)	Phase 2

See all OXYBUTYNIN CHLORIDE clinical trials

Pharmacology for OXYBUTYNIN CHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for OXYBUTYNIN CHLORIDE

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osmotica Pharm Us	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	078503-001	Feb 4, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	208165-001	Dec 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010-003	Nov 23, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unique	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	206121-002	May 27, 2016	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 CHLORIDE

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

International Patents for OXYBUTYNIN CHLORIDE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20120030078	A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS	⤷ Sign Up
European Patent Office	2427172	PROCÉDÉ 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)	⤷ Sign Up
European Patent Office	3287122	DISPOSITIF DE STOCKAGE ET D'ADMINISTRATION DE COMPOSITIONS TOPIQUES D'OXYBUTYNINE DANS LE CADRE DU TRAITEMENT DE VESSIES HYPERACTIVES (DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS FOR TREATING OVERACTIVE BLADDERS.)	⤷ Sign Up
Australia	2010246103	A method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions	⤷ Sign Up
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.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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