Oxytrol Drug Patent Profile

When do Oxytrol patents expire, and when can generic versions of Oxytrol launch?

Oxytrol is a drug marketed by Allergan and Abbvie and is included in two NDAs.

The generic ingredient in OXYTROL is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for Oxytrol

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	7
Patent Applications:	3,925
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Oxytrol
What excipients (inactive ingredients) are in Oxytrol?	Oxytrol excipients list
DailyMed Link:	Oxytrol at DailyMed

See drug prices for Oxytrol

See drug sales revenues for Oxytrol

Recent Clinical Trials for Oxytrol

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

Sponsor	Phase
Astellas Scientific & Medical Affairs, Inc.
Christopher Patrick Smith	Phase 3
Bayer	Phase 3

See all Oxytrol clinical trials

Pharmacology for Oxytrol

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for Oxytrol

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

Paragraph IV (Patent) Challenges for OXYTROL

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 Oxytrol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003		RX	Yes	Yes
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013		OTC	Yes	Yes

Expired US Patents for Oxytrol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 Oxytrol

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 Oxytrol

See the table below for patents covering Oxytrol around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	306249	matrix patch containing triacetin as a transdermal pentration enhancer
Japan	2013082720	MINIMIZATION OF ADVERSE EXPERIENCE ASSOCIATED OXYBUTYNIN THERAPY
China	101843601	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Norway	20161918	Preparater for transdermal oksybutyninterapi

Supplementary Protection Certificates for Oxytrol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0871420	05C0008	France		PRODUCT NAME: OXYBUTININ; REGISTRATION NO/DATE: EU/1/03/270/001 20040615
0871420	CA 2005 00010	Denmark