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Oxybutynin - Generic Drug Details

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

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, Par Pharm Inc, Ortho Mcneil Janssen, Anda Repository, 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, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in forty NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has one hundred and twenty patent family members in twenty-three countries.

There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.

Summary for oxybutynin

International Patents:	120
US Patents:	13
Tradenames:	8
Applicants:	34
NDAs:	40
Drug Master File Entries:	16
Suppliers / Packagers:	1
Bulk Api Vendors:	70
Clinical Trials:	86
Patent Applications:	4,237
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for oxybutynin
Drug Sales Revenues:	Drug sales revenues for oxybutynin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxybutynin
DailyMed Link:	oxybutynin at DailyMed

See drug prices for oxybutynin

See drug sales revenues for oxybutynin

Recent Clinical Trials for oxybutynin

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Alliance for Clinical Trials in Oncology	Phase 2
Apnimed	Phase 2

See all oxybutynin clinical trials

Pharmacology for oxybutynin

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for OXYBUTYNIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
OXYTROL	FILM, EXTENDED RELEASE;TRANSDERMAL	oxybutynin	021351	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
Quantum Pharmics	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	072296-001	Dec 8, 1988		DISCN	No	No
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	AB	RX	Yes	No
Anda Repository	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	075039-001	Jan 29, 1999		DISCN	No	No
Teva Pharms Usa	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	071655-001	Nov 14, 1988	AB	RX	No	No
Novitium Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209823-001	Oct 23, 2017	AB	RX	No	No
Amneal Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010-002	Nov 23, 2015	AB	RX	No	No
Amneal Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010-003	Nov 23, 2015	AB	RX	No	No

Expired US Patents for oxybutynin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011

International Patents for oxybutynin

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004041187
New Zealand	546106
South Korea	100856523
South Africa	200602046
Germany	60143477
South Africa	200505985
World Intellectual Property Organization (WIPO)	2004041188