Oxybutynin - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for oxybutynin and what is the scope of patent protection?

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, 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 forty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for oxybutynin

US Patents:	3
Tradenames:	8
Applicants:	34
NDAs:	42
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	98
Patent Applications:	6,524
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

Drug Sales Revenue Trends for oxybutynin

See drug sales revenues for oxybutynin

Recent Clinical Trials for oxybutynin

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

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2

See all oxybutynin clinical trials

Pharmacology for oxybutynin

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for oxybutynin

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	075039-001	Jan 29, 1999	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unique	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	206121-001	May 27, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	214415-003	Oct 27, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leading	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	212798-001	Apr 6, 2020	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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	⤷ Sign Up	⤷ Sign Up
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for oxybutynin

Subscribe to access the full database, or Sign Up
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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.