Oxybutynin - Generic Drug Details

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, 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 Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in forty-two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has fifty-five patent family members in twenty countries.

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

Summary for oxybutynin

International Patents:	55
US Patents:	4
Tradenames:	8
Applicants:	34
NDAs:	42
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	90
Patent Applications:	6,747
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
What excipients (inactive ingredients) are in oxybutynin?	oxybutynin excipients list
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
Science Valley Research Institute	Phase 2
Samantha Rodrigues Camargo Neves de Moura	Phase 2
Northwestern University	N/A

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	Strength	NDA	ANDAs Submitted	Submissiondate
OXYTROL	Transdermal System Extended-release	oxybutynin	3.9 mg/24 hrs	021351	1	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
Allergan	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009		RX	Yes	Yes			Y
Rubicon	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	214415-002	Oct 27, 2020	AB	RX	No	No
Unique Pharm Labs	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	206121-003	May 27, 2016	AB	RX	No	No
Beximco Pharms Usa	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	213550-001	Jul 14, 2022	AB	RX	No	No
Zydus Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	202332-003	Jun 26, 2017	AB	RX	No	No
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	AB	RX	Yes	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 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	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003

EU/EMA Drug Approvals for oxybutynin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Kentera (previously Oxybutynin Nicobrand)	oxybutynin	EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.	Authorised	no	no	no	2004-06-15

International Patents for oxybutynin

Country	Patent Number	Title	Estimated Expiration
Australia	2001282064
South Africa	200602046	Transdermal pharmaceutical formulation for minimizing skin residues
Hong Kong	1225311
Japan	5441966
Japan	2007508261
Spain	2283425