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Last Updated: April 16, 2024

OXYBUTYNIN - Generic Drug Details

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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, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Eywa, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, 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:	35
NDAs:	42
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	94
Patent Applications:	6,526
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

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
Cairo University	Phase 3
Benha University	N/A
Samantha Rodrigues Camargo Neves de Moura	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	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

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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
Strides Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	075079-001	Oct 31, 1997	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Tulex Pharms Inc	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	210125-001	Sep 6, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Unique	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	206121-003	May 27, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209025-001	Dec 21, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Try a Trial	⤷ Try a Trial
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Try a Trial	⤷ Try a Trial
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011	⤷ Try a Trial	⤷ Try a Trial
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for OXYBUTYNIN

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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

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